Bioavailability Study of PF-06651600 Formulations in Healthy Participants

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04004663
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-06651600	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 RELATIVE TO TABLETS IN HEALTHY PARTICIPANTS
• Actual Study Start Date: Jul 15, 2019
• Actual Primary Completion Date: Oct 11, 2019
• Actual Study Completion Date: Oct 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Sequence 1 Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment A); Period 2 (Treatment B); Period 3 (Treatment C); Period 4 (Treatment D).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Experimental: Treatment Sequence 2 Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment B); Period 2 (Treatment D); Period 3 (Treatment A); Period 4 (Treatment C).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Experimental: Treatment Sequence 3 Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment C); Period 2 (Treatment A); Period 3 (Treatment D); Period 4 (Treatment B).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Experimental: Treatment Sequence 4 Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment D); Period 2 (Treatment C); Period 3 (Treatment B); Period 4 (Treatment A).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600 [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

2. Maximum plasma PF-06651600 concentration (C max) [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

Secondary Outcome Measures

1. Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600 [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

2. Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600 [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

3. Single dose plasma decay half-life (t 1/2) of PF-06651600 [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

4. Single dose Apparent Oral Clearance (CL/F) of PF-06651600 [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

5. Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600 [Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.]

6. Frequency of abnormal safety laboratory tests [Baseline up to day 9]

7. Frequency of Adverse Events [Baseline up to Day 35]

Eligibility Criteria

Criteria

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

INCLUSION CRITERIA:

• Participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.

• Participants with body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight

50 kg (110 lb).

EXCLUSION CRITERIA

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

• Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.

• Infection with hepatitis B or hepatitis C viruses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brussels Clinical Research Unit	Brussels	Be-bru	Belgium	B-1070

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: NCT04004663
• Other Study ID Numbers: B7981022; 2019-001452-19
• First Posted: Jul 2, 2019
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Pfizer: pharmacokinetics; JAK inhibitor; PF-06651600

Study Results

No Results Posted as of Nov 1, 2019