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

NCT04390776 | Completed Phase 1 FDA Drug

• 1 other identifier: B7981029
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

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

• 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 Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).

Drug: PF-06651600

Treatment Sequence 2

EXPERIMENTAL

PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).

Drug: PF-06651600

Treatment Sequence 3

EXPERIMENTAL

PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).

Drug: PF-06651600

Treatment Sequence 4

EXPERIMENTAL

PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).

Drug: PF-06651600

Interventions

PF-06651600 DRUG

PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.

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:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Related Publications (1)

• 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

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: May 14, 2020
• First Posted: May 18, 2020
• Study Start: September 28, 2020
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)