Información:
Error:
ID
38138
Descripción
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
Palabras clave
Versiones (1)
- 21/9/19 21/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
21 de septiembre de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036
Eligibility Question
- StudyEvent: ODM
Similar models
Eligibility Question
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (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])
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])
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])
C1305855 (UMLS CUI [2])
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])
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])
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])
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])
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])
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])
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])
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])
C0086839 (UMLS CUI [2])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])