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NCT01756781 · ClinicalTrials.gov registry record · Phase 1

A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT01756781 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 26 participants.

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The verdict

NCT01756781, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2. Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in treatment period 1, and following a washout period of no less than 14 days they will receive midazolam alone in treatment period 2.

Interventions

  • DRUG Midazolam
  • DRUG PD-0332991

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2013-05
Est. Completion 2013-07
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01756781

The ClinicalTrials.gov registry entry for NCT01756781 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.

NCT01756781 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01756781 about?

NCT01756781 is a clinical study titled "A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.". This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be randomized to one of two sequenc...

What is the current status of trial NCT01756781?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-05. Estimated completion is 2013-07.

What interventions are being tested in trial NCT01756781?

The interventions under investigation include: Midazolam (DRUG), PD-0332991 (DRUG).

Who is sponsoring clinical trial NCT01756781?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.