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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02224651
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 9
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06650833; Drug: Placebo; Drug: PF-06650833; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 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 Substitution, Crossover, Single Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf 06650833 Delivered In Multiple Formulations In Healthy Subjects Under Fasted And Fed Conditions
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (1-1000mg) Immediate Release formulation	Drug: PF-06650833; Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions.
Placebo Comparator: Immediate Release Placebo arm	Drug: Placebo; Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions.
Experimental: (10-500) mg Modified Release formulation	Drug: PF-06650833; Subjects will receive sequential single escalating doses of 10-500 mg of Modified Release of PF-06650833 (as capsule) under fed and / or fasted conditions.
Placebo Comparator: Modified Release Placebo arm	Drug: Placebo; Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as capsule) under fed and/ or fasted conditions.

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events [Baseline-5 days]

2. Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure) [Baseline-5 days]

3. Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry) [Baseline-5 days]

   Quantitative changes in ECG intervals

4. 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

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02224651
• Other Study ID Numbers: B7921001; IRAK4 FIH
• First Posted: Aug 25, 2014
• Last Update Posted: Jul 2, 2015
• Last Verified: Jul 1, 2015

Study Results

No Results Posted as of Jul 2, 2015