A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
- 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium