NCT01217918 is a Phase 1 clinical trial of 1 mg in Healthy, sponsored by Pfizer.

Who is sponsoring NCT01217918?

NCT01217918 is sponsored by Pfizer.

What drugs are being tested in NCT01217918?

Interventions in NCT01217918: 1 mg, 5 mg, 10 mg.

Is NCT01217918 still recruiting?

NCT01217918 is currently completed. Last updated 14 February 2011.

Last reviewed 2011-02-14 · How we verify

NCT01217918

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

APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects

Completed Phase 1 Last updated 14 February 2011

What this trial tests

Phase 1 trial testing 1 mg in Healthy in 30 participants. Completed in 1 February 2011.

Timeline

1 October 2010

Primary endpoint
1 February 2011

1 February 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	30
Start date	1 October 2010
Primary completion	1 February 2011
Estimated completion	1 February 2011
Sites	2 locations across United States

Drugs / interventions tested

1 mg — full drug profile →
5 mg — full drug profile →
10 mg

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.

Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
Time frame: Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements
Time frame: Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters
Time frame: Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
Time frame: Days 1 and 10

Sponsor's own description

Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.

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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NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
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
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

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 NCT01217918 (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: 14 February 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/NCT01217918.

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