Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation

NCT04065633 | Completed Phase 1 FDA Drug

• 1 other identifier: B7451032
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Part A

• To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
• To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions
• To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation Part B
• To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions Parts A \& B
• To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize \[break down\] certain medications) o Genotyping is the collection of a small sample of blood that contains your genes
• To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants
• To measure the amount of study drug in the blood after single doses of the different formulations
• To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing

Conditions

Dermatitis, Atopic

Keywords

Phase 1 Bioequivalence Study; Healthy Participants; Estimation of the Effect of Food; Relative Bioavailability

Outcome Measures

Primary Outcomes (2)

• Plasma PF-04965842 PK parameters

  AUCinf

  hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose

• Plasma PF-04965842 PK parameters

  Cmax

  hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose

Secondary Outcomes (3)

• number of subjects with treatment-emergent adverse event

  baseline until Period 4 study day 35

• number of subjects with significant change from baseline in Supine Blood pressure, pulse rate and oral temperature

  baseline until Period 4 study day 3

• number of subjects with significant Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR

  baseline until Period 4 study day 3

Study Arms (4)

Part A sequence 1

EXPERIMENTAL

Drug: P3-Fast; Drug: Comm-Fast; Drug: Vari-Fast; Drug: Comm-Fed

Part A sequence 2

EXPERIMENTAL

Drug: P3-Fast; Drug: Comm-Fast; Drug: Vari-Fast; Drug: Comm-Fed

Part B sequence 1

EXPERIMENTAL

Drug: P3-Fast; Drug: Comm-Fast

Part B sequence 2

EXPERIMENTAL

Drug: P3-Fast; Drug: Comm-Fast

Interventions

P3-Fast DRUG

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

Part A sequence 1; Part A sequence 2; Part B sequence 1; Part B sequence 2

Comm-Fast DRUG

200 mg PF-04965842 commercial tablet formulation under fasted conditions

Part A sequence 1; Part A sequence 2; Part B sequence 1; Part B sequence 2

Vari-Fast DRUG

200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions

Part A sequence 1; Part A sequence 2

Comm-Fed DRUG

200 mg PF-04965842 commercial tablet formulation under fed conditions

Part A sequence 1; Part A sequence 2

Eligibility Criteria

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

You may qualify if:

• 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:

• Any condition possibly affecting drug absorption (eg, gastrectomy).
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis
• Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) .History of tuberculosis (TB) (active or latent) or inadequately treated TB infection.
• History of chronic infections, history of recurrent infections, history of latent infections, .History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
• history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Sylvester Pawlak, APRN

  Pfizer

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a Phase 1 randomized, open label, single-dose, crossover study in healthy participants to estimate the rBA of the commercial formulation of PF-04965842 (Test formulation 1) and the variant formulation with slower dissolution (Test formulation 2) compared to the Phase 3 formulation (Reference formulation), to demonstrate the BE of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the rBA of the commercial formulation after a single 200 mg oral dose.

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: August 22, 2019
• Study Start: July 18, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)