NCT02131298 is a Phase 1 clinical trial of Palbociclib Alone in Healthy, sponsored by Pfizer.

Who is sponsoring NCT02131298?

NCT02131298 is sponsored by Pfizer.

What drugs are being tested in NCT02131298?

Interventions in NCT02131298: Palbociclib Alone, Palbociclib plus itraconazole.

Is NCT02131298 still recruiting?

NCT02131298 is currently completed. Last updated 27 June 2014.

Last reviewed 2014-06-27 · How we verify

NCT02131298

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1, Open-Label, Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Single Dose Pharmacokinetics of Palbociclib (PD-0332991) In Healthy Volunteers

Completed Phase 1 Last updated 27 June 2014

What this trial tests

Phase 1 trial testing Palbociclib Alone in Healthy in 12 participants. Completed in 1 June 2014.

Timeline

1 May 2014

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	1 May 2014
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	1 location across United States

Drugs / interventions tested

Palbociclib Alone — full drug profile →
Palbociclib plus itraconazole — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 0 to 168 hours
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 to 168 hours

Sponsor's own description

This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Cyclin D1, cancer progression, and opportunities in cancer treatment.
Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3

Verify or expand the search:

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Other Pfizer trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02131298 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 27 June 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02131298.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing