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NCT01161836 · ClinicalTrials.gov registry record · Phase 1

An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
7
Enrollment target

NCT01161836: Completed Phase 1 study, sponsored by Sanofi.

NCT01161836 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01161836, a Phase 1 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

This is a Phase 1, multi-center, open-label study. During Segment 1, patients are administered a single IV administration of \[14C\]-iniparib. During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.

Interventions

  • DRUG Iniparib

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-07
Est. Completion 2011-06
Phase Phase 1
Sanofi

713 total trials

What the finished NCT01161836 record still lists

NCT01161836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

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

NCT01161836 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01161836 about?

NCT01161836 is a clinical study titled "An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)". This is a Phase 1, multi-center, open-label study. During Segment 1, patients are administered a single IV administration of \[14C\]-iniparib. During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for whic...

What is the current status of trial NCT01161836?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2010-07. Estimated completion is 2011-06.

What interventions are being tested in trial NCT01161836?

The interventions under investigation include: Iniparib (DRUG).

Who is sponsoring clinical trial NCT01161836?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01161836's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 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 NCT01161836, the US trial registry maintained by the National Library of Medicine. NCT01161836 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.