NCT01370343 is a Phase 1 clinical trial of PF-04991532 alone in Healthy, sponsored by Pfizer.

Who is sponsoring NCT01370343?

NCT01370343 is sponsored by Pfizer.

What drugs are being tested in NCT01370343?

Interventions in NCT01370343: PF-04991532 alone, PF-04991532 + cyclosporine.

What condition does NCT01370343 study?

NCT01370343 studies Healthy, Drug Interaction.

Is NCT01370343 still recruiting?

NCT01370343 is currently completed. Last updated 3 September 2011.

Last reviewed 2011-09-03 · How we verify

NCT01370343

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

A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Healthy Adult Subjects

Completed Phase 1 Last updated 3 September 2011

What this trial tests

Phase 1 trial testing PF-04991532 alone in Healthy in 12 participants. Completed in 1 July 2011.

Timeline

1 July 2011

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	1 July 2011
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across Belgium

Drugs / interventions tested

PF-04991532 alone — full drug profile →
PF-04991532 + cyclosporine — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →
Drug Interaction — all drugs for Drug Interaction →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy or Drug Interaction. 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 plasma concentration versus time profile (AUC)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Max observed plasma concentration (Cmax)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose

Sponsor's own description

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine.

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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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 NCT01370343 (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: 3 September 2011

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/NCT01370343.

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