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A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants

NCT ID: NCT05431153

Last Updated: 2024-04-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2022-10-17

Brief Summary

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This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Open-label Study

Study Groups

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PF-07104091 Sequence 1

Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.

Group Type EXPERIMENTAL

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation D (Treatment D)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.

PF-07104091 Sequence 2

Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.

Group Type EXPERIMENTAL

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation D (Treatment D)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.

PF-07104091 Sequence 3

Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.

Group Type EXPERIMENTAL

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation D (Treatment D)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.

PF-07104091 Sequence 4

Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.

Group Type EXPERIMENTAL

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment E)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.

PF-07104091 Sequence 5

Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.

Group Type EXPERIMENTAL

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment E)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.

PF-07104091 Sequence 6

Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.

Group Type EXPERIMENTAL

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Single dose of PF-07104091 as Tablet Formulation C (Treatment E)

Intervention Type DRUG

A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.

Interventions

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Single dose of PF-07104091 as Tablet Formulation A (Treatment A)

A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.

Intervention Type DRUG

Single dose of PF-07104091 as Tablet Formulation B (Treatment B)

A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.

Intervention Type DRUG

Single dose of PF-07104091 as Tablet Formulation C (Treatment C)

A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.

Intervention Type DRUG

Single dose of PF-07104091 as Tablet Formulation D (Treatment D)

A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.

Intervention Type DRUG

Single dose of PF-07104091 as Tablet Formulation C (Treatment E)

A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.

Intervention Type DRUG

Other Intervention Names

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Tablet Formulation A, Fasted Tablet Formulation B, Fasted Tablet Formulation C, Fasted Tablet Formulation D, Fasted Tablet Formulation C, Fed

Eligibility Criteria

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Inclusion Criteria

* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
* Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of \>50 kg (110 lb).
* Written evidence of a personally signed and dated informed consent document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
* 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).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* 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.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* A positive urine drug test.
* History of sensitivity to heparin or heparin induced thrombocytopenia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

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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New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4161007

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

Other Identifiers

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C4161007

Identifier Type: -

Identifier Source: org_study_id

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