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NCT02159352 · ClinicalTrials.gov registry record · Phase 1

Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants

A Phase 1 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT02159352: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT02159352 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02159352, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.

Primary Outcome

Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.

Interventions

  • DRUG Ritonavir
  • DRUG Lopinavir/Ritonavir
  • DRUG Darunavir
  • DRUG Daclatasvir

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2014-06
Est. Completion 2014-07
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT02159352 record still lists

NCT02159352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).

The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.

NCT02159352 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02159352 about?

NCT02159352 is a clinical study titled "Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants". The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.

What is the current status of trial NCT02159352?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2014-06. Estimated completion is 2014-07.

What interventions are being tested in trial NCT02159352?

The interventions under investigation include: Ritonavir (DRUG), Lopinavir/Ritonavir (DRUG), Darunavir (DRUG), Daclatasvir (DRUG).

Who is sponsoring clinical trial NCT02159352?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02159352's enrollment target sits among peer trials

49 1017th of 2000 higher than 976 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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Source: ClinicalTrials.gov NCT02159352, the US trial registry maintained by the National Library of Medicine. NCT02159352 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.