ID

38138

Description

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Keywords

Versions (1)
  1. 9/21/19 9/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 21, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

English

Eligibility Question

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Question
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Females of child bearing potential who are 18 to 45 years of age, inclusive.
Description

Gender, Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
Negative Pregnancy test at screening and throughout the study. Subjects must adhere to the contraceptive methods as detailed in section 7.4 which includes, abstinence, documented tubal ligation for greater than one year prior to enrollment in this study, documented placement of an intrauterine device (IUD) with a documented failure rate of less than 1% per year, double-barrier methods - a spermicide plus mechanical barrier (e.g. spermicide plus a male condom or female diaphragm).
Description

Pregnancy; Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
Body weight > 50 kg (110 pounds) and Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Description

Body Weight; Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
History of smoking within six months of the first dose of study medication
Description

Smoking History

Data type

boolean

Alias
UMLS CUI [1]
C1519384
Positive urine cotinine at screening
Description

Urine cotinine test, Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C1446409
Abuse of alcohol, defined, for females, as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits, or 1 glass (125mL of wine).
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
History of anaphylaxis or anaphalactoid reactions, severe allergic responses to drugs
Description

Hypersensitivity, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0262926
Positive urine drug, alcohol or serum pregnancy test at screening or prior to dosing in any study session
Description

Urine drug screen; Ethanol measurement; Pregnancy Tests

Data type

boolean

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2]
C0202304
UMLS CUI [3]
C0032976
Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening
Description

Hepatitis C antibody positive; Hepatitis B surface antigen positive; HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0019699
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding first dose of medication
Description

Experimental drug, Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205394
Use of prescription or non-prescription drugs (other than paracetamol at doses of ≤ 2g/day) within 7 days or 5 half-lives (whichever is longer) prior to first dose of medication
Description

Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng, red yeast rice, and vitamins (2-fold greater than the recommended daily allowance) within 14 days prior to first dose of medication
Description

Dietary Supplements; Herbal Supplements; Vitamin supplement

Data type

boolean

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2]
C1504473
UMLS CUI [3]
C0681579
Consumption of grapefruit or grapefruit juice within 7 days prior to first dose of medication
Description

Grapefruit, Grapefruit juice

Data type

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0452456
Donation of blood in excess of 500 mL within 56 days prior to first dose of medication
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
QTc ≥ 450 msec at screening
Description

QTc Interval

Data type

boolean

Alias
UMLS CUI [1]
C0489625
Lactating, and/or less than 6 months post-partum or 6 months after confirmed pregnancy ending in spontaneous abortion or miscarriage
Description

Breast Feeding; Postpartum period

Data type

text

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0086839
Pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Question

1 forms
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender, Age
Item
Females of child bearing potential who are 18 to 45 years of age, inclusive.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Pregnancy; Contraceptive methods
Item
Negative Pregnancy test at screening and throughout the study. Subjects must adhere to the contraceptive methods as detailed in section 7.4 which includes, abstinence, documented tubal ligation for greater than one year prior to enrollment in this study, documented placement of an intrauterine device (IUD) with a documented failure rate of less than 1% per year, double-barrier methods - a spermicide plus mechanical barrier (e.g. spermicide plus a male condom or female diaphragm).
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Body Weight; Body mass index
Item
Body weight > 50 kg (110 pounds) and Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Comorbidity
Item
Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
boolean
C0009488 (UMLS CUI [1])
Smoking History
Item
History of smoking within six months of the first dose of study medication
boolean
C1519384 (UMLS CUI [1])
Urine cotinine test, Positive
Item
Positive urine cotinine at screening
boolean
C1697737 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Alcohol abuse
Item
Abuse of alcohol, defined, for females, as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits, or 1 glass (125mL of wine).
boolean
C0085762 (UMLS CUI [1])
Hypersensitivity, Medical History
Item
History of anaphylaxis or anaphalactoid reactions, severe allergic responses to drugs
boolean
C0020517 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Urine drug screen; Ethanol measurement; Pregnancy Tests
Item
Positive urine drug, alcohol or serum pregnancy test at screening or prior to dosing in any study session
boolean
C0202274 (UMLS CUI [1])
C0202304 (UMLS CUI [2])
C0032976 (UMLS CUI [3])
Hepatitis C antibody positive; Hepatitis B surface antigen positive; HIV Seropositivity
Item
Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Experimental drug, Other
Item
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding first dose of medication
boolean
C0304229 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Concomitant Agent
Item
Use of prescription or non-prescription drugs (other than paracetamol at doses of ≤ 2g/day) within 7 days or 5 half-lives (whichever is longer) prior to first dose of medication
boolean
C2347852 (UMLS CUI [1])
Dietary Supplements; Herbal Supplements; Vitamin supplement
Item
Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng, red yeast rice, and vitamins (2-fold greater than the recommended daily allowance) within 14 days prior to first dose of medication
boolean
C0242295 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C0681579 (UMLS CUI [3])
Grapefruit, Grapefruit juice
Item
Consumption of grapefruit or grapefruit juice within 7 days prior to first dose of medication
boolean
C0995150 (UMLS CUI [1,1])
C0452456 (UMLS CUI [1,2])
Blood Donation
Item
Donation of blood in excess of 500 mL within 56 days prior to first dose of medication
boolean
C0005794 (UMLS CUI [1])
QTc Interval
Item
QTc ≥ 450 msec at screening
boolean
C0489625 (UMLS CUI [1])
Breast Feeding; Postpartum period
Item
Lactating, and/or less than 6 months post-partum or 6 months after confirmed pregnancy ending in spontaneous abortion or miscarriage
text
C0006147 (UMLS CUI [1])
C0086839 (UMLS CUI [2])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
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