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NCT01458054 · ClinicalTrials.gov registry record · Phase 1
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01458054: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01458054 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458054, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
Primary Outcome
PK parameter
Interventions
- DRUG Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)
- DRUG Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-09-27 |
| Est. Completion | 2011-11-28 |
| Phase | Phase 1 |
What the finished NCT01458054 record still lists
NCT01458054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) is the first listed.
NCT01458054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458054 about?
NCT01458054 is a clinical study titled "Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults". This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
What is the current status of trial NCT01458054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-09-27. Estimated completion is 2011-11-28.
What interventions are being tested in trial NCT01458054?
The interventions under investigation include: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) (DRUG), Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) (DRUG).
Who is sponsoring clinical trial NCT01458054?
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 NCT01458054's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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