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

Purpose

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	Intervention	Phase
Healthy	Drug: PF-06282999 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to 24 hour [AUC24] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose ] [ Designated as safety issue: No ]
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24) [ Time Frame: 0 to 24 hours post-dose ] [ Designated as safety issue: No ]
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%) [ Time Frame: 0 to 24 hours post-dose ] [ Designated as safety issue: No ]
Renal Clearance (CLr) [ Time Frame: 0 to 24 hours post-dose ] [ Designated as safety issue: No ]
Oral temperature [ Time Frame: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	June 2012
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626976

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01626976 History of Changes
Other Study ID Numbers:	B5211001
Study First Received:	May 30, 2012
Last Updated:	March 12, 2013
Health Authority:	European Union: European Medicines Agency

Keywords provided by Pfizer:

safety
tolerability
pharmacokinetics
oral

single ascending dose
placebo-controlled
healthy subjects

ClinicalTrials.gov processed this record on May 19, 2013