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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580797
• Other study ID #: B7931058
• Status: Completed
• Phase: Phase 1
• Start date: October 2, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-06700841 IR
Immediate release formulation
• PF-06700841 MR1
Modified release formulation 1
• PF-06700841 MR2
Modified release formulation 2
• PF-06700841 MR3
Modified release formulation 3

Other:
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Quotient Sciences	Coral Gables	Florida
United States	Quotient Sciences-Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A		pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Primary	Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A		pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Primary	Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A		pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Primary	Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A		pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Primary	Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B		Baseline to Day 10
Secondary	Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A		Pre-dose and 96 hours post dose
Secondary	Number of subjects with clinically relevant changes in vital signs in Part A		Pre-dose and 96 hours post dose
Secondary	Number of participants with clinically relevant changes in clinical laboratory tests in Part A		Baseline and 96 hours post dose
Secondary	Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A		Baseline to Day 4
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1		pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1
Secondary	Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1		pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7		pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
Secondary	Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7		pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
Secondary	Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1		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
Secondary	Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7		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
Secondary	Terminal half-life of PF-06700841 in Part B		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

External Links

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