Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06650833; Drug: Placebo

• Registration Number: NCT02224651
• Lead Sponsor: Pfizer

Brief Summary

This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals are to assess the safety, tolerability and blood levels of ascending doses of multiple formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on exposure, in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Study Start: 2014-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria

• Screening supine blood pressure 100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
• Pulse or heart rate (HR) >100 bpm after at least 5 minutes of rest. If the pulse/HR is >100 bpm, the pulse/HR should be repeated two more times (separated by at least 2 minutes) and the average of the three pulse/HR values should be used to determine the subject's eligibility.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
(1-1000mg) Immediate Release formulation	PF-06650833	-
Immediate Release Placebo arm	Placebo	-
(10-500) mg Modified Release formulation	PF-06650833	-
Modified Release Placebo arm	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events	Baseline-5 days
Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure)	Baseline-5 days
Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry)	Baseline-5 days	Quantitative changes in ECG intervals
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry (including, cardiac enzymes CK, CK MB and cardiac Troponin I), serum myoglobin, urinalysis	Baseline-5 days

Secondary Outcome Measures

Name	Time	Method
Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fasted condition	Baseline-5 days
Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fed condition	Baseline-5 days

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States