Information:
Fel:
ID
36179
Beskrivning
Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia
Nyckelord
Versioner (1)
- 2019-04-22 2019-04-22 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
22 april 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963
Similar models
Screening
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan (2)
CL Item
Native Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Vital Signs Time
Item
Actual Time
text
C2826762 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Vital Signs, Body Position
Item
Subject Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
C1262869 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Disease, Diagnosis
Item
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item
Current or Past?
text
C0012634 (UMLS CUI [1,1])
C1444635 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
Drug screen, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
C0002667 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
C0006864 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
C0004745 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Ethanol measurement, breath, Date in time
Item
Date sample taken
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Results
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item Group
Serology - HIV Screen
C0459958 (UMLS CUI-1)
C0036743 (UMLS CUI-2)
C0036743 (UMLS CUI-2)
HIV screen, Serologic tests, Sampling, Date in time
Item
Date sample taken
date
C0459958 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0036743 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Electronically transferred laboratory data - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C0018941 (UMLS CUI-2)
Chemistry, Clinical, Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Chemistry, Clinical, Hematologic tests, Sampling, Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Sampling, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Holter Electrocardiography, Start Date
Item
Start date of ECG
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography, Start Time
Item
Start time of ECG
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography, End Date
Item
End date of ECG
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography, End Time
Item
End time of ECG
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
12 lead ECG, End Date
Item
End Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Sreening (Sreening)
12 lead ECG, Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
12 lead ECG, End Time
Item
End Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
12 lead ECG, QT corrected Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
Sinus bradycardia (heart rate< 30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate > 100 beats/min) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
Junctional rhythm (heart rate ~100 beats/min) (14)
CL Item
Junctional rhythm (15)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
ldioventricular rhythm (heart rate< 100 beats/min) (24)
CL Item
Sustained ventricular tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Ventricular tachycardia (27)
CL Item
Mononnorphic ventricular tachycardia (28)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (29)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (30)
CL Item
Artificial pacemaker (31)
CL Item
Other abnormal rhythm (32)
Item
P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
Code List
P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
lnlraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval> 200 msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch blo (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS 120 msec) (15)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (16)
CL Item
QT/QTc prolongation >= 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Item
Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non-Q wave (7)
CL Item
Other myocardial infarction (8)
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
12 lead ECG, Abnormality, Other
Item
Other Abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Health Status; Tobacco use; Age; Pregnancy; Breastfeeding
Item
Healthy, non-smoking, adult men or non pregnant, non-lactating women between 18 and 50 years of age inclusive.
boolean
C0018759 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
C0543414 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
post-Menopause; Hysterectomy; Contraceptive usage
Item
A female subject may be entered into the study if she is: Post-menopausal females defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by estradiol and FSH levels consistent with menopause (according to local laboratory ranges) Pre-menopausal females with a documented hysterectomy (medical report verification and/or bilateral oophorectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Childbearing potential females must use one of the following methods of contraception: 1.Abstinence. The lifestyle of the female should be such that there is complete abstinence from intercourse from at least the commencement of their last normal period prior to the first dose of study medication and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest. 2. One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective otherwise it should be used with a barrier method (condom or occlusive cap {diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/ suppository): documented tubal ligation. Documented placement of a non-hormonal intrauterine device (IUD) or intrauterine system (IUS). 3. Male partner sterilization (vasectomy) prior to the female subject's entry into the study and is the sole partner for that female subject. 4. Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/ cream/suppository.
boolean
C0206159 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C0009899 (UMLS CUI [3])
C0020699 (UMLS CUI [2])
C0009899 (UMLS CUI [3])
Body Weight; Body mass index
Item
Bodyweight>/= 50 kg (110 lbs)formen and>/= 45 kg for women and BMI within the range 18.5-29.9 kg/m2 inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C1305855 (UMLS CUI [2])
Health status
Item
Healthy as judged by responsible physician no clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead ECG, vital signs. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator, in discussion with the GSK Medical Monitor when necessary considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
boolean
C0018759 (UMLS CUI [1])
QT interval
Item
Subject has a QT interval within the normal range at screening
boolean
C1287082 (UMLS CUI [1])
Informed Consent
Item
Signed and dated written informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol- stated restrictions.
boolean
C0525058 (UMLS CUI [1])
Exanthema, Drug-induced
Item
History of drug-induced skin rash
boolean
C0015230 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0458082 (UMLS CUI [1,2])
Syncope
Item
istory of clinically significant fainting
boolean
C0039070 (UMLS CUI [1])
Hypotension, Orthostatic
Item
History of clinically significant orthostatic hypotension
boolean
C0020651 (UMLS CUI [1])
Hypotension
Item
History of clinically significant low blood pressure (i.e. the subject has received a diagnosis of 'low blood pressure' from his/her GP, or has a history of symptoms suggestive of low blood pressure
boolean
C0020649 (UMLS CUI [1])
Systolic pressure; Diastolic blood pressure
Item
Subjects with systolic BP<100mmHg or diastolic BP<60mmHg.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
Seizures
Item
History of seizure of any type, including febrile convulsions
boolean
C0036572 (UMLS CUI [1])
Craniocerebral Trauma
Item
History of clinically significant head injury (e.g. resulting in skull fracture or loss of consciousness) or head injury requiring hospitalisation
boolean
C0018674 (UMLS CUI [1])
Poor metabolizer; cytochrome p450 2D6 genotype
Item
Subjects who are poor metabolisers of cytochrome P450 206 (either documented history or test performed at screening). Subjects found to be homozygous for variants in the CYP206 gene associated with very low or no enzyme activity will be excluded.
boolean
C3845231 (UMLS CUI [1,1])
C2164095 (UMLS CUI [1,2])
C2164095 (UMLS CUI [1,2])
Hypotension, Orthostatic
Item
Subjects with symptomatic postural hypotension.
boolean
C0020651 (UMLS CUI [1])
Blood Pressure, Decrease
Item
Subjects with a drop in systolic BP of>20mmHg and diastolic>1 OmmHg without symptoms of postural hypotension at screening.
boolean
C0005823 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C0547047 (UMLS CUI [1,2])
Urine drug test; Ethanol measurement, breath
Item
The subject has a positive pre-study urine drug/ alcohol breath test screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines
boolean
C0202274 (UMLS CUI [1])
C0202306 (UMLS CUI [2])
C0202306 (UMLS CUI [2])
HIV Antibodies; Hepatitis B surface antigen; Hepatitis C antibody
Item
A positive pre-study HIV 1/2, Hepatitis B surface antigen and positive Hepatitis C antibody result within 3 months of the start of the study
boolean
C0019683 (UMLS CUI [1,1])
C0369334 (UMLS CUI [1,2])
C0166049 (UMLS CUI [1,3])
C0369334 (UMLS CUI [1,2])
C0166049 (UMLS CUI [1,3])
Substance Use Disorders; Alcohol Abuse
Item
History or evidence of drug or alcohol abuse within 6 months of study start. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 1 unit is equivalent to a half-pint (220ml) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
boolean
C0038586 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0085762 (UMLS CUI [2])
Study Subject Participation Status
Item
The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
boolean
C2348568 (UMLS CUI [1])
Pharmaceutical Preparations; Vitamins; Dietary Supplements; Herbal Supplements; Anti-Inflammatory Agents, Non-Steroidal
Item
Use of prescription or non-prescription drugs, including vitamins and dietary supplements wihtin 48 hours prior to dosing; herbal supplements (including St John'sWort) and NSAIDs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the each PK day, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
boolean
C0013227 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C0042890 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
Hormonal Contraception; Hormone Replacement therapy
Item
Female subjects using hormonal methods of contraception (including progestogen-coated IUD or IUS) or hormone replacement therapy.
boolean
C2985296 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
C0282402 (UMLS CUI [2])
Pharmaceutical Preparations, Hypersensitivity
Item
History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
boolean
C0013227 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Gastrointestinal Diseases; Liver diseases; Kidney Diseases; Drug Metabolism Alteration
Item
History of gastrointestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs;
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1512073 (UMLS CUI [4])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1512073 (UMLS CUI [4])
Grapefruit; Cytochrome P450 3A4 Inducer
Item
The subject has eaten grapefruit, grapefruit juice, watercress, broccoli, brussel sprouts or cabbage within seven days before the first study day until the end of the last PK sampling day. These vegetables may induce the synthesis metabolic phase-1 enzymes (CYP enzyme activity) and phase 2 enzymes (conjugating enzymes i.e. glucuronidases, sulphatases).
boolean
C0995150 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
C3830625 (UMLS CUI [2])
Blood Donation
Item
Where participation in study would result in donation of blood in excess of 500 m l within a 56 day period.
boolean
C0005794 (UMLS CUI [1])
Strenuous Exercise; Abstinence
Item
Subjects must refrain from strenuous exercise for 48 hours before the screening medical examination and the PK sampling days and for 24 hours afterwards
boolean
C1514989 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C3843422 (UMLS CUI [1,2])
Alcohol Abstinence; Caffeine, Abstinence
Item
Subjects must refrain from alcohol and caffeine for 48 hours prior to and including PK sampling days.
boolean
C0678274 (UMLS CUI [1])
C0006644 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0006644 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])