Clinical trial NCT04580797: Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations
Official title: A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS IN PART A AND A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06700841 FOLLOWING MULTIPLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATION UNDER FASTED CONDITION IN PART B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition.

Part B is a multiple ascending dose study
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
timeFrame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
measure: Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A
timeFrame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
measure: Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A
timeFrame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
measure: Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A
timeFrame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
measure: Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B
timeFrame: Baseline to Day 10
Secondary outcomes:
measure: Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A
timeFrame: Pre-dose and 96 hours post dose
measure: Number of subjects with clinically relevant changes in vital signs in Part A
timeFrame: Pre-dose and 96 hours post dose
measure: Number of participants with clinically relevant changes in clinical laboratory tests in Part A
timeFrame: Baseline and 96 hours post dose
measure: Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A
timeFrame: Baseline to Day 4
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1
timeFrame: pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1
measure: Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1
timeFrame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7
timeFrame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
measure: Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7
timeFrame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
measure: Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1
timeFrame: 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
measure: Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7
timeFrame: 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
measure: Terminal half-life of PF-06700841 in Part B
timeFrame: 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
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Quotient Sciences
state: Florida
city: Miami
country: United States
facility: Quotient Sciences-Miami
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: