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NCT01197911 · ClinicalTrials.gov registry record · Phase 1
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01197911: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01197911 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197911, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.
Primary Outcome
AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.
Interventions
- DRUG aleglitazar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01197911 record still lists
NCT01197911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which aleglitazar is the first listed.
NCT01197911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197911 about?
NCT01197911 is a clinical study titled "A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar". This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single...
What is the current status of trial NCT01197911?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-09. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01197911?
The interventions under investigation include: aleglitazar (DRUG).
Who is sponsoring clinical trial NCT01197911?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197911's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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