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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 7 participants.

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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

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT01161836

The ClinicalTrials.gov registry entry for NCT01161836 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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

NCT01161836 reports 0 study locations.

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.

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.