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

NCT ID: NCT04580797

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2021-01-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Part B is a sponsor open, double blind study where the investigator, medical monitor and the participants will be blinded.

Study Groups

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PF-06700841: IR, MR1, MR2, MR1_fed

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

Group Type EXPERIMENTAL

PF-06700841 IR

Intervention Type DRUG

Immediate release formulation

PF-06700841 MR1

Intervention Type DRUG

Modified release formulation 1

PF-06700841 MR2

Intervention Type DRUG

Modified release formulation 2

PF-06700841: MR1, MR2, IR, MR1_fed

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

Group Type EXPERIMENTAL

PF-06700841 IR

Intervention Type DRUG

Immediate release formulation

PF-06700841 MR1

Intervention Type DRUG

Modified release formulation 1

PF-06700841 MR2

Intervention Type DRUG

Modified release formulation 2

PF-06700841: MR2, IR, MR1, MR1_fed

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

Group Type EXPERIMENTAL

PF-06700841 IR

Intervention Type DRUG

Immediate release formulation

PF-06700841 MR1

Intervention Type DRUG

Modified release formulation 1

PF-06700841 MR2

Intervention Type DRUG

Modified release formulation 2

PF-06700841: IR, MR1, MR2, MR2_fed

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

Group Type EXPERIMENTAL

PF-06700841 IR

Intervention Type DRUG

Immediate release formulation

PF-06700841 MR1

Intervention Type DRUG

Modified release formulation 1

PF-06700841 MR2

Intervention Type DRUG

Modified release formulation 2

PF-06700841: MR1, MR2, IR, MR2_fed

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

Group Type EXPERIMENTAL

PF-06700841 IR

Intervention Type DRUG

Immediate release formulation

PF-06700841 MR1

Intervention Type DRUG

Modified release formulation 1

PF-06700841 MR2

Intervention Type DRUG

Modified release formulation 2

PF-06700841: MR2, IR, MR1, MR2_fed

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

Group Type EXPERIMENTAL

PF-06700841 IR

Intervention Type DRUG

Immediate release formulation

PF-06700841 MR1

Intervention Type DRUG

Modified release formulation 1

PF-06700841 MR2

Intervention Type DRUG

Modified release formulation 2

PF-06700841 MR3 (Dose A) or matching placebo

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

Group Type EXPERIMENTAL

PF-06700841 MR3

Intervention Type DRUG

Modified release formulation 3

Placebo

Intervention Type OTHER

Matching placebo

PF-06700841 MR3 (Dose B) or matching placebo

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

Group Type EXPERIMENTAL

PF-06700841 MR3

Intervention Type DRUG

Modified release formulation 3

Placebo

Intervention Type OTHER

Matching placebo

PF-06700841 MR3 (Dose C) or matching placebo

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

Group Type EXPERIMENTAL

PF-06700841 MR3

Intervention Type DRUG

Modified release formulation 3

Placebo

Intervention Type OTHER

Matching placebo

Interventions

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PF-06700841 IR

Immediate release formulation

Intervention Type DRUG

PF-06700841 MR1

Modified release formulation 1

Intervention Type DRUG

PF-06700841 MR2

Modified release formulation 2

Intervention Type DRUG

PF-06700841 MR3

Modified release formulation 3

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Quotient Sciences

Coral Gables, Florida, United States

Site Status

Quotient Sciences-Miami

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7931058

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

Other Identifiers

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B7931058

Identifier Type: -

Identifier Source: org_study_id

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