First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961.

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: PF-06882961
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb) Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer). Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. | Drug: PF-06882961<br>* Single Ascending Doses of PF-06882961 from 3mg to TBD mg.<br>Other: Placebo<br>* Placebo Single Dose<br>|
| Experimental: Cohort 2<br>Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. | Drug: PF-06882961<br>* Single Ascending Doses of PF-06882961 from 3mg to TBD mg.<br>Other: Placebo<br>* Placebo Single Dose<br>|
| Experimental: Cohort 3 (optional)<br>Single Ascending Dose administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. | Drug: PF-06882961<br>* Single Ascending Doses of PF-06882961 from 3mg to TBD mg.<br>Other: Placebo<br>* Placebo Single Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Seriousness and Relationship to Treatment | Assessment by adverse event monitoring, 12 lead ECGs, cardiac telemetry, vital signs and clinical safety laboratory measurements. | First dose of study drug up to 28 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration | 
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration |