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NCT01797536 · ClinicalTrials.gov registry record · Phase 1
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
A Phase 1 study of Hepatic Insufficiency, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01797536: Completed Phase 1 study of Hepatic Insufficiency, sponsored by Merck Sharp & Dohme.
NCT01797536 is a Phase 1 study of Hepatic Insufficiency that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 31 participants, below the 38-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (18% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797536, a Phase 1 study of Hepatic Insufficiency, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
Primary Outcome
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.
Conditions Studied
Interventions
- DRUG Elbasvir
Study Locations (2)
Florida
- Call for Information (Investigational Site 0003) - Miami
- Call for Information (Investigational Site 0001) - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-03-06 |
| Est. Completion | 2014-08-20 |
| Phase | Phase 1 |
What the finished NCT01797536 record still lists
NCT01797536 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 38-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Hepatic Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Elbasvir is the first listed.
NCT01797536 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01797536 about?
NCT01797536 is a clinical study titled "The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)". The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
What is the current status of trial NCT01797536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-03-06. Estimated completion is 2014-08-20.
What conditions does trial NCT01797536 study?
This clinical trial studies the following conditions: Hepatic Insufficiency.
What interventions are being tested in trial NCT01797536?
The interventions under investigation include: Elbasvir (DRUG).
Who is sponsoring clinical trial NCT01797536?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01797536 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Insufficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01797536's enrollment target sits among peer trials
31 12th of 14 higher than 3 of 14 other Hepatic Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Insufficiency 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.
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