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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 38 participants.
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.
Interventions
- DRUG aleglitazar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01197911
The ClinicalTrials.gov registry entry for NCT01197911 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which aleglitazar is the first listed.
NCT01197911 reports 0 study locations.
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.
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