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

NCT05431153 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-08

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DRUG

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.

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.

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.

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2022-10-17
Completion
2022-10-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05431153 on ClinicalTrials.gov