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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06282999; Drug: Placebo

• Registration Number: NCT01626976
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 2	Placebo	-
Cohort 3	PF-06282999	-
Cohort 3	Placebo	-
Cohort 4	PF-06282999	-
Cohort 4	Placebo	-
Cohort 5	PF-06282999	-
Cohort 1	PF-06282999	-
Cohort 1	Placebo	-
Cohort 2	PF-06282999	-
Cohort 5	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium