Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04390776
• Collaborator: (none)
• Enrollment: 164
• Locations: 2
• Arms: 4
• Actual Duration (Months): 9.7
• Patients Per Site: 82
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 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 EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS
• Actual Study Start Date: Sep 28, 2020
• Actual Primary Completion Date: Jul 19, 2021
• Actual Study Completion Date: Jul 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Sequence 1 PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Experimental: Treatment Sequence 2 PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Experimental: Treatment Sequence 3 PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Experimental: Treatment Sequence 4 PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.

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 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

2. Maximum plasma PF-06651600 concentration (C max) [Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

Secondary Outcome Measures

1. Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600 [Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

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 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

3. Single dose plasma decay half-life (t 1/2) of PF-06651600 [Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

4. Single dose Apparent Oral Clearance (CL/F) of PF-06651600 [Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

5. Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600 [Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.]

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:

• Male and female 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 cardiac evaluation (including ECG).

• 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 (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), 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.

Participants with any of the following acute or chronic infections or infection history:

• Any infection requiring treatment within 2 weeks prior to the dosing visit.

• Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.

• Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.

• Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.

• History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Centers of America ( Hollywood )	Hollywood	Florida	United States	33024
2	Prism Research LLC dba Nucleus Network	Saint Paul	Minnesota	United States	55114

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: NCT04390776
• Other Study ID Numbers: B7981029
• First Posted: May 18, 2020
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• 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

Study Results

No Results Posted as of Aug 4, 2021