Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics 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

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01794364

Enrollment

Registered

2013-02-18

Start date

2013-01-31

Completion date

2013-03-31

Last updated

2013-04-04

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

Conditions

Healthy

Keywords

T2DM, Diabetes Mellitus Type 2

Brief summary

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.

Interventions

DRUGPF-06291874

PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.

OTHERplacebo

Correspondingly, placebo doses will be administered as suspension.

Study design

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0-72/dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]	0-72/dose
Maximum Observed Plasma Concentration (Cmax)	0-72/dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0-72/dose
Plasma Decay Half-Life (t1/2)	0-72/dose
Apparent Oral Clearance (CL/F)	0-72/dose
Apparent Volume of Distribution (Vz/F)	0-72/dose

Countries

United States

Outcome results

None listed

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