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NCT01610388 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01610388: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01610388 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610388, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
This first time in human (FTIH) study will be the first administration of GSK1322322 as an intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute bioavailability of an oral tablet formulation as compared to the IV formulation.In addition, Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.
Interventions
- DRUG 500mg IV GSK1322322/placebo
- DRUG 1000mg oral GSK1322322/placebo
- DRUG 1000mg IV GSK1322322/placebo
- DRUG 1500mg oral GSK1322322/placebo dose
- DRUG 1500mg IV GSK1322322/placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-09-13 |
| Est. Completion | 2012-01-26 |
| Phase | Phase 1 |
What the finished NCT01610388 record still lists
NCT01610388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which 500mg IV GSK1322322/placebo is the first listed.
NCT01610388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610388 about?
NCT01610388 is a clinical study titled "A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects". This first time in human (FTIH) study will be the first administration of GSK1322322 as an intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for determination of GSK1322322 con...
What is the current status of trial NCT01610388?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2011-09-13. Estimated completion is 2012-01-26.
What interventions are being tested in trial NCT01610388?
The interventions under investigation include: 500mg IV GSK1322322/placebo (DRUG), 1000mg oral GSK1322322/placebo (DRUG), 1000mg IV GSK1322322/placebo (DRUG), 1500mg oral GSK1322322/placebo dose (DRUG), 1500mg IV GSK1322322/placebo (DRUG).
Who is sponsoring clinical trial NCT01610388?
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 NCT01610388's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 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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