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NCT01669083 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01669083: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01669083 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01669083, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This study will be the first dosing experience with this compound in women. It is important to characterize the pharmacokinetics of GSK557296 in women to determine the most appropriate doses and dosing regimens for future clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable more accurate characterization of any exposure-response relationship in future studies. Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10 milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging study to characterize the pharmacokinetics of GSK557296 in women to determine the most appropriate doses and dosing regimens for future clinical studies. This is a non-randomized, open label, adaptive design study in healthy female volunteers. A maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1 will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive based on the requirement of additional doses to be studies after PK data will be analyzed from each of the first 2 cohorts.
Primary Outcome
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve \[AUC(0-t) and AUC(0-infinity)\], and apparent terminal phase half-life (t1/2). AUC(0-infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Interventions
- DRUG GSK557296 10 mg
- DRUG GSK557296 150 mg
- DRUG GSK557296 dose 3
- DRUG GSK557296 dose 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-08-16 |
| Est. Completion | 2013-03-09 |
| Phase | Phase 1 |
What the finished NCT01669083 record still lists
NCT01669083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which GSK557296 10 mg is the first listed.
NCT01669083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01669083 about?
NCT01669083 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing". GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This study will be the first dosing experience with this compound in women. It is important to characterize the pharmacokinetics of GSK557296 in women to determ...
What is the current status of trial NCT01669083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-08-16. Estimated completion is 2013-03-09.
What interventions are being tested in trial NCT01669083?
The interventions under investigation include: GSK557296 10 mg (DRUG), GSK557296 150 mg (DRUG), GSK557296 dose 3 (DRUG), GSK557296 dose 4 (DRUG).
Who is sponsoring clinical trial NCT01669083?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01669083's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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