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NCT02045940 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of GSK2881078 in Single and Repeat Doses
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT02045940: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02045940 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02045940, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
This study is the first administration of GSK2881078 to humans. The intention of this study is to provide sufficient confidence in the safety of the molecule to inform progression to further repeat dose and proof of concept studies. This study will include approximately 52 subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5) will include three cohorts of 12 healthy male subjects to examine the safety, tolerability, PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration of the study including screening and follow-up, is not expected to exceed 70 days.
Primary Outcome
Vital signs include: systolic blood pressure, diastolic blood pressure and heart rate
Interventions
- DRUG Placebo
- DRUG GSK2881078
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2014-01-20 |
| Est. Completion | 2015-03-26 |
| Phase | Phase 1 |
What the finished NCT02045940 record still lists
NCT02045940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02045940 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02045940 about?
NCT02045940 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of GSK2881078 in Single and Repeat Doses". This study is the first administration of GSK2881078 to humans. The intention of this study is to provide sufficient confidence in the safety of the molecule to inform progression to further repeat dose and proof of concept studies. This study will include approximately 52 subjects and consist of 2 ...
What is the current status of trial NCT02045940?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2014-01-20. Estimated completion is 2015-03-26.
What interventions are being tested in trial NCT02045940?
The interventions under investigation include: Placebo (DRUG), GSK2881078 (DRUG).
Who is sponsoring clinical trial NCT02045940?
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 NCT02045940's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 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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