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NCT01762462 · ClinicalTrials.gov registry record · Phase 1

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

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

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT01762462: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT01762462 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01762462, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.

Interventions

  • DRUG SAR302503

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2012-12
Est. Completion 2013-03
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01762462 record still lists

NCT01762462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 1 intervention - of which SAR302503 is the first listed.

NCT01762462 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01762462 about?

NCT01762462 is a clinical study titled "Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment". Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects w...

What is the current status of trial NCT01762462?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-12. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01762462?

The interventions under investigation include: SAR302503 (DRUG).

Who is sponsoring clinical trial NCT01762462?

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 NCT01762462's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 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 NCT01762462, the US trial registry maintained by the National Library of Medicine. NCT01762462 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.