NCT06393517

A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults

A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF IMMEDIATE-RELEASE AND MODIFIED-RELEASE FORMULATIONS OF PF-06954522 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare three finished products of PF-06954522 in terms of the uptake into the blood stream. This study is seeking participants who are: \- Healthy male or female participants aged 18 years or older. All participants in this study will receive PF-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522. The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given. Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	PF-06954522 IR (Formulation 1)	Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth
DRUG	PF-06954522 MR (Formulation 2)	Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.
DRUG	PF-06954522 MR (Formulation 3)	Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2024-05-01
• Last updated: 2024-10-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study