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NCT02961660 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT02961660 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 16 participants.

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The verdict

NCT02961660, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.

Interventions

  • DRUG Odalasvir

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2016-11-09
Est. Completion 2018-04-09
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT02961660

The ClinicalTrials.gov registry entry for NCT02961660 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Odalasvir is the first listed.

NCT02961660 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02961660 about?

NCT02961660 is a clinical study titled "A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir". The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.

What is the current status of trial NCT02961660?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-11-09. Estimated completion is 2018-04-09.

What interventions are being tested in trial NCT02961660?

The interventions under investigation include: Odalasvir (DRUG).

Who is sponsoring clinical trial NCT02961660?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.