Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02567773 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT02567773: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02567773 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02567773, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for effects on muscle growth and strength in subjects with muscle wasting to improve their physical function. Part A of this study will evaluate the safety, efficacy and pharmacokinetics of GSK2881078 in healthy, older men and post-menopausal women who will take daily dosing for 28 days and be followed for a total of 70 days. Part B of this study will characterize the effect of Cytochrome P450 3A4 (CYP3A4) inhibition on the GSK2881078 pharmacokinetics. Part B will only be conducted if safe and efficacious dose is identified in Part A. Part A will include healthy older males and post-menopausal females; and randomize approximately 60 subjects (about 15 per cohort \[4 cohorts\]) to complete approximately 48 (about 12 per cohort). Part B will enroll one cohort of approximately 15 healthy male subjects to complete approximately 12. The study duration will be approximately 115 days for Part A and 122 days for Part B.
Primary Outcome
Blood pressure will be recorded whilst the subject is in a semi -supine position, having rested in this position for at least 10 minutes.
Interventions
- DRUG Placebo
- DRUG Itraconazole
- DRUG GSK2881078
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT02567773 record still lists
NCT02567773 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02567773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02567773 about?
NCT02567773 is a clinical study titled "Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078". GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for effects on muscle growth and strength in subjects with muscle wasting to improve their physical function. Part A of this study will evaluate the safety, efficacy and pharmacokinetics of GSK2881078 in healthy, ol...
What is the current status of trial NCT02567773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2015-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02567773?
The interventions under investigation include: Placebo (DRUG), Itraconazole (DRUG), GSK2881078 (DRUG).
Who is sponsoring clinical trial NCT02567773?
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 NCT02567773's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02703207 · 108 participants · NA
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
- NCT02744677 · 108 participants · NA
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
- NCT02781883 · 108 participants · Phase 2
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
- NCT03848663 · 108 participants · NA
Visual Remapping to Aid Reading With Field Loss
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia