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NCT03627494 · ClinicalTrials.gov registry record · Phase 1
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT03627494: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03627494 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03627494, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients. The study design is based on pre-clinical findings for GSK3439171A, contributing to the frequency, type and duration of safety assessment and monitoring during treatment periods in each cohort. The single dose assessments in Part A will be conducted to determine safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the study intervention in individuals before progressing to doses explored further in other parts of the study and will allow for any adjustments needed based on emerging safety, tolerability, and PK information. Part A will also serve to identify a dose for use in examining the effect of food on GSK3439171A exposure in Part C. In Part B, a single dose safety, tolerability and PK will be collected followed by progression of these subjects to the repeat dose portion of the study. The up to 14-day dosing was chosen as it is thought to provide sufficient safety and tolerability data to bridge to longer duration studies. The dosing period can be adjusted depending on PK and PD data collected in Part A of the study. Part B will involve more detailed PK/PD/metabolite assessments to better understand the impact of GSK3439171A on target engagement and metabolism in humans. Approximately 150 subjects will be screened to achieve 75 randomly assigned to study intervention. Duration for Part A, B and C will be approximately 10 weeks, 9 weeks and 8 weeks respectively.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events
Interventions
- DRUG Placebo
- DRUG GSK3439171A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-08-30 |
| Est. Completion | 2019-08-26 |
| Phase | Phase 1 |
What the finished NCT03627494 record still lists
NCT03627494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03627494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03627494 about?
NCT03627494 is a clinical study titled "First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect". The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients. The study design is based on pre-clinical findings for GSK3439171A, contributing to the frequency, type and duration ...
What is the current status of trial NCT03627494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2018-08-30. Estimated completion is 2019-08-26.
What interventions are being tested in trial NCT03627494?
The interventions under investigation include: Placebo (DRUG), GSK3439171A (DRUG).
Who is sponsoring clinical trial NCT03627494?
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 NCT03627494's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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