NCT01796327 is a Phase 1 clinical trial of dacomitinib oral in Healthy Volunteers, sponsored by Pfizer.

Who is sponsoring NCT01796327?

NCT01796327 is sponsored by Pfizer.

What drugs are being tested in NCT01796327?

Interventions in NCT01796327: dacomitinib oral, dacomitinib intravenous.

What condition does NCT01796327 study?

NCT01796327 studies Healthy Volunteers.

Is NCT01796327 still recruiting?

NCT01796327 is currently completed. Last updated 6 October 2015.

Last reviewed 2015-10-06 · How we verify

NCT01796327

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, Fixed Sequence Study To Estimate The Absolute Bioavailability Of Dacomitinib (PF-00299804) By Comparing Oral To Intravenous Administration In Healthy Volunteers

Completed Phase 1 Last updated 6 October 2015

What this trial tests

Phase 1 trial testing dacomitinib oral in Healthy Volunteers in 14 participants. Completed in 1 June 2013.

Timeline

1 April 2013

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	14
Start date	1 April 2013
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	1 location across United Kingdom

Drugs / interventions tested

dacomitinib oral
dacomitinib intravenous — 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.

Dacomitinib Dose-normalized Area under the Concentration-Time Curve (AUC) From Time Zero to Extrapolated Infinite Time following oral dose
Time frame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. normalized to the administered dose
Dacomitinib Dose-normalized Area under the Concentration-Time Curve (AUC) From Time Zero to Extrapolated Infinite Time following intravenous dose
Time frame: 0, 0.5, 1, 1.083, 1.25, 1.5, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. normalized to the administered dose

Sponsor's own description

This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is taken up from the digestive tract into the body when given as an oral tablet compared with that taken up by an intravenous dose.

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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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 NCT01796327 (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: 6 October 2015

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/NCT01796327.

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