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NCT01827657 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01827657: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01827657 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827657, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a single-dose, open-label, two part, parallel group study. This study is being conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects with mild and moderate hepatic impairment and healthy control subjects matched to the subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be based on a review of the preliminary safety and pharmacokinetic data from subjects with moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment. Additionally, based on emergent data from Part 1, matched controls to the severe hepatic group may be enrolled (optional). Due to the potential difficulty in identifying eligible subjects with severe hepatic impairment, the study may be stopped prior to full enrollment in Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic impairment have been enrolled. The study will consist of a Screening visit, a single dose Treatment Period and a Follow-up visit. Subjects will be screened for eligibility criteria within 30 days of enrolment. Subjects will be admitted to the clinical unit on Day -1; each subject will receive a single dose of GSK2336805 on Day 1 and will remain in the clinical unit for 5 days (check-out on Day 4). The follow-up visit will be conducted within 7-10 days after Day 1 dosing.
Primary Outcome
The following pharmacokinetic parameters will be determined: area under the plasma concentration time curve (AUC)- from time zero to infinity \[AUC(0-inf)\], from time zero to the last quantifiable time points \[AUC(0-t)\], and from time zero to 24 hours \[AUC(0-24)\]; maximum observed plasma concentration (Cmax); time to Cmax (tmax); concentration at 24hour post-dose (C24); absorption lag time (tlag); apparent oral clearance (CL/F), apparent volume of distribution after oral administration (Vz/
Interventions
- DRUG GSK2336805
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-05-28 |
| Est. Completion | 2014-03-20 |
| Phase | Phase 1 |
What the finished NCT01827657 record still lists
NCT01827657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK2336805 is the first listed.
NCT01827657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01827657 about?
NCT01827657 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects". This is a single-dose, open-label, two part, parallel group study. This study is being conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects with mild and moderate hepatic im...
What is the current status of trial NCT01827657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-05-28. Estimated completion is 2014-03-20.
What interventions are being tested in trial NCT01827657?
The interventions under investigation include: GSK2336805 (DRUG).
Who is sponsoring clinical trial NCT01827657?
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 NCT01827657's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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