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NCT01471717 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects
A Phase 1 study of Healthy, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01471717: Completed Phase 1 study of Healthy, sponsored by Bristol-Myers Squibb.
NCT01471717 is a Phase 1 study of Healthy that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 32 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471717, a Phase 1 study of Healthy, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
Primary Outcome
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination: maximum observed plasma concentration (Cmax), time at which Cmax is observed (Tmax), plasma concentration at the end of dosing interval (Ctau), area under the plasma concentration-time curve from time 0 to the end of dosing interval (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F), as applicable
Conditions Studied
Interventions
- DRUG INX-08189 50 mg QD X 5 days
- DRUG INX-08189 / Victrelis 800 mg TID X three days
- DRUG Victrelis 800 mg TID x 3 days
- DRUG Victrelis 800 mg TID with INX-08189 50 mg QD
- DRUG Placebo with Victrelis 800 mg
Study Locations (1)
Minnesota
- Prism Research, LLC - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-10 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01471717 record still lists
NCT01471717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which INX-08189 50 mg QD X 5 days is the first listed.
NCT01471717 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01471717 about?
NCT01471717 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects". This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
What is the current status of trial NCT01471717?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-10. Estimated completion is 2011-11.
What conditions does trial NCT01471717 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01471717?
The interventions under investigation include: INX-08189 50 mg QD X 5 days (DRUG), INX-08189 / Victrelis 800 mg TID X three days (DRUG), Victrelis 800 mg TID x 3 days (DRUG), Victrelis 800 mg TID with INX-08189 50 mg QD (DRUG), Placebo with Victrelis 800 mg (DRUG).
Who is sponsoring clinical trial NCT01471717?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01471717 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT01471717's enrollment target sits among peer trials
32 647th of 1090 higher than 418 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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