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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01797536
The ClinicalTrials.gov registry entry for NCT01797536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 38-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (18% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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