CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Single dose of PF-07104091 as Tablet Formulation A (Treatment A) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05431153
NCT05431153Phase 1Completed
CompareCT.gov

A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, 5-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE BIOAVAILABILITY OF PF-07104091

Pfizer·interventional·Posted Jun 24, 2022·Updated Apr 8, 2024

In Brief

A Phase 1 clinical trial evaluating Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation B (Treatment B), and 3 other interventions for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJun 24, 2022
Enrollment StartJun 10, 2022
Primary CompletionOct 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.0 years ago

Interventions

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

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

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

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