Trials / Completed
CompletedNCT05431153
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-06-10
- Primary completion
- 2022-10-17
- Completion
- 2022-10-17
- First posted
- 2022-06-24
- Last updated
- 2024-04-08
- Results posted
- 2024-04-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05431153. Inclusion in this directory is not an endorsement.