A Single Dose Study Of PF-06291874 In Healthy Adult Subjects

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01499017

Enrollment

Registered

2011-12-26

Start date

2011-11-30

Completion date

2012-01-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Single Ascending Dose Study in healthy subjects

Brief summary

The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

Detailed description

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers. The trial was terminated on Jan 9, 2012, due to undesired pharmacokinetic properties. The decision to terminate the trial was not based on any safety or efficacy concerns.

Interventions

DRUGPF-06291874 or placebo

PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 3 mg to 100 mg. Correspondingly, placebo doses will be administered as suspension.

DRUGPF-06291874 or Placebo

PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 300 mg to 650 mg. Correspondingly, placebo doses will be administered as suspension.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects of non childbearing potential. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Design outcomes

Primary

Measure	Time frame
Safety and tolerability data: number of subjects with adverse events and Laboratory Test Values of Potential Clinical Importance, Changes from baseline in pulse rate, blood pressure and Electrocardiogram (ECG) measurements over 48 hrs	2 days/dose group
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group
Maximum Observed Plasma Concentration (Cmax) fasted - 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group
Time to Reach Maximum Observed Plasma Concentration (Tmax) -fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group
Plasma Decay Half-Life (t1/2) fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group
Apparent Oral Clearance (CL/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group
Apparent Volume of Distribution (V/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs	2 days/dose group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026