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

Pfizer36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Participants

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Quotient Sciences

Coral Gables, Florida, United States

Quotient Sciences-Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A

Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A

Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A

Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A

Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B

Time frame: Baseline to Day 10

Secondary Outcomes

Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A

Time frame: Pre-dose and 96 hours post dose

Number of subjects with clinically relevant changes in vital signs in Part A

Time frame: Pre-dose and 96 hours post dose

Number of participants with clinically relevant changes in clinical laboratory tests in Part A

Time frame: Baseline and 96 hours post dose

Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A

Time frame: Baseline to Day 4

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1

Time frame: pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1

Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1

Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7

Time frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7

Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7

Time frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7

Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1

Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7

Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

Terminal half-life of PF-06700841 in Part B

Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7