NCT01749085 is a Phase 1 clinical trial of PF-04449913, ketoconazole in Healthy Volunteers, sponsored by Pfizer.

Who is sponsoring NCT01749085?

NCT01749085 is sponsored by Pfizer.

What drugs are being tested in NCT01749085?

Interventions in NCT01749085: PF-04449913, ketoconazole, PF-04449913, ketoconazole.

What condition does NCT01749085 study?

NCT01749085 studies Healthy Volunteers.

Is NCT01749085 still recruiting?

NCT01749085 is currently completed. Last updated 8 April 2013.

Last reviewed 2013-04-08 · How we verify

NCT01749085

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 Study In Healthy Subjects To Estimate The Effect Of Food And The Drug-Drug Interaction Potential Of Ketoconazole On PF-04449913 Pharmacokinetics

Completed Phase 1 Last updated 8 April 2013

What this trial tests

Phase 1 trial testing PF-04449913, ketoconazole in Healthy Volunteers in 14 participants. Completed in 1 February 2013.

Timeline

1 December 2012

Primary endpoint
1 February 2013

1 February 2013

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	14
Start date	1 December 2012
Primary completion	1 February 2013
Estimated completion	1 February 2013
Sites	1 location across United States

Drugs / interventions tested

PF-04449913, ketoconazole — full drug profile →
PF-04449913, ketoconazole — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Pfizer — full company profile →

Who can join

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

What's being measured

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

Maximum Observed Plasma Concentration (Cmax)
Time frame: 8 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 8 days

Sponsor's own description

The study aims to determine what effect a high fat meal will have on the drug exposure of PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4) inhibitor on drug exposure of PF-04449913.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Pfizer trials

Trials by the same sponsor.

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NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
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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 NCT01749085 (US National Library of Medicine, public domain)
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: 8 April 2013

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/NCT01749085.

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