A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01626976

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06282999 Drug: Placebo Drug: PF-06282999 Drug: Placebo Drug: PF-06282999 Drug: Placebo Drug: PF-06282999 Drug: Placebo Drug: PF-06282999 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1	Drug: PF-06282999 Solution, doses range from 20 to 200 mg, single dose Drug: Placebo Solution, single dose
Experimental: Cohort 2	Drug: PF-06282999 Methylcellulose suspension, doses range 125 to 500 mg, single dose Drug: Placebo suspension, single dose
Experimental: Cohort 3	Drug: PF-06282999 Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose Drug: Placebo suspension, single dose
Experimental: Cohort 4	Drug: PF-06282999 Methylcellulose or simethicone suspension, 500 mg dose, single dose Drug: Placebo suspension, single dose
Experimental: Cohort 5	Drug: PF-06282999 Simethicone or methylcellulose suspension, up to 1500 mg, single dose Drug: Placebo suspension, single dose

Outcome Measures

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Area Under the Curve From Time Zero to 24 hour [AUC24] [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose]
Maximum Observed Plasma Concentration (Cmax) [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Apparent Oral Clearance (CL/F) [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Plasma Decay Half-Life (t1/2) [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Apparent Volume of Distribution (Vz/F) [0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose]
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24) [0 to 24 hours post-dose]
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%) [0 to 24 hours post-dose]
Renal Clearance (CLr) [0 to 24 hours post-dose]
Oral temperature [0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Women must be of non-childbearing potential.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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 time of dosing).
Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.