Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-06700841 MR2; Other: Placebo; Drug: PF-06700841 MR3; Drug: PF-06700841 MR1; Drug: PF-06700841 IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT04580797

B7931058

Details and patient eligibility

About

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female participants between 18 -55 years of age.
• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
• Participants who are willing and able to comply with all scheduled visits, treatment
• plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
• History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
• Positive urine drug test.
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 9 patient groups

PF-06700841: IR, MR1, MR2, MR1_fed

Experimental group

Description:

Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4

Treatment:

Drug: PF-06700841 MR2

Drug: PF-06700841 MR1

Drug: PF-06700841 IR

PF-06700841: MR1, MR2, IR, MR1_fed

Experimental group

Description:

Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4

Treatment:

Drug: PF-06700841 MR2

Drug: PF-06700841 MR1

Drug: PF-06700841 IR

PF-06700841: MR2, IR, MR1, MR1_fed

Experimental group

Description:

Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4

Treatment:

Drug: PF-06700841 MR2

Drug: PF-06700841 MR1

Drug: PF-06700841 IR

PF-06700841: IR, MR1, MR2, MR2_fed

Experimental group

Description:

Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4

Treatment:

Drug: PF-06700841 MR2

Drug: PF-06700841 MR1

Drug: PF-06700841 IR

PF-06700841: MR1, MR2, IR, MR2_fed

Experimental group

Description:

Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4

Treatment:

Drug: PF-06700841 MR2

Drug: PF-06700841 MR1

Drug: PF-06700841 IR

PF-06700841: MR2, IR, MR1, MR2_fed

Experimental group

Description:

Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4

Treatment:

Drug: PF-06700841 MR2

Drug: PF-06700841 MR1

Drug: PF-06700841 IR

PF-06700841 MR3 (Dose A) or matching placebo

Experimental group

Description:

Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition

Treatment:

Other: Placebo

Drug: PF-06700841 MR3

PF-06700841 MR3 (Dose B) or matching placebo

Experimental group

Description:

Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition

Treatment:

Other: Placebo

Drug: PF-06700841 MR3

PF-06700841 MR3 (Dose C) or matching placebo

Experimental group

Description:

Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition

Treatment:

Other: Placebo

Drug: PF-06700841 MR3