Bioavailability Study of PF-06651600 Formulations in Healthy Participants

NCT04004663 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79810222019-001452-19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

pharmacokinetics; JAK inhibitor; PF-06651600

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

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

Treatment Sequence 2

EXPERIMENTAL

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

Treatment Sequence 3

EXPERIMENTAL

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

Treatment Sequence 4

EXPERIMENTAL

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

Interventions

PF-06651600 DRUG

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

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

Brussels, Be-bru, B-1070, Belgium

Location

Related Publications (2)

• Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.

  PMID: 38267790 DERIVED

• Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

  PMID: 37917289 DERIVED

Related Links

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

MeSH Terms

Interventions

PF-06651600

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: July 15, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)