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

Study Description

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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	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
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 :	June 2012
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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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

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Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
5. 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 ]
6. Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
7. 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 ]
8. 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 ]
9. Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24) [ Time Frame: 0 to 24 hours post-dose ]
10. Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%) [ Time Frame: 0 to 24 hours post-dose ]
11. Renal Clearance (CLr) [ Time Frame: 0 to 24 hours post-dose ]
12. Oral temperature [ Time Frame: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

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Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01626976 History of Changes
Other Study ID Numbers:	B5211001
First Posted:	June 25, 2012
Last Update Posted:	March 13, 2013
Last Verified:	March 2013

Keywords provided by Pfizer:

safety; tolerability; pharmacokinetics; oral	single ascending dose; placebo-controlled; healthy subjects