CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
PF-06821497 Treatment A +5 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/NCT05767905
NCT05767905Phase 1Completed

A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497

Pfizer·interventional·Posted Mar 14, 2023·Updated Jun 12, 2025

In Brief

A Phase 1 clinical trial evaluating PF-06821497 Treatment A, PF-06821497 Treatment B, and 4 other interventions for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants. The study is seeking for male and female participants who: * Are 18 years of age or more. * Are confirmed to be healthy after performing some medical and physical tests. * Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more. The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period. Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions. How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants. In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.

Study Details

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

Timeline

Phase 1CompletedFinished
202420252026
First PostedMar 14, 2023
Enrollment StartMar 17, 2023
Primary CompletionJun 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.3 years ago

Interventions

PF-06821497 Treatment Adrug

A single dose of PF-06821497 administered under fasting conditions.

PF-06821497 Treatment Bdrug

A single dose of PF-06821497 administered under fasting conditions.

PF-06821497 Treatment Cdrug

A single dose of PF-06821497 administered under fasting conditions.

PF-06821497 Treatment Ddrug

A single dose of PF-06821497 administered under fasting conditions.

PF-06821497 Treatment Edrug

A single dose of PF-06821497 administered after low fat meal

PF-06821497 Treatment Fdrug

A single dose of PF-06821497 administered after high fat meal.