A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Pfizer
- Study ID
- NCT07575945
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Healthy Participant
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- PF-08642534 — DRUGParticipants will receive a single dose of PF-08642534
- Itraconazole — DRUGParticipants will receive itraconazole once daily for 13 days (Day 12 to Day 24)
Study Details
The purpose of this study is to learn if a medicine called itraconazole changes how the body processes the study medicine (PF-08642534) in healthy adults. This study is seeking healthy participants (men or women) who: * are aged 18 to 65 years of age * are confirmed to be healthy by their medical history and medical tests * have body mass index (BMI) of 16 to 30 kilograms per meter squared * have a total body weight of more than 50 kilograms. Participants will receive single doses of the study medicine (PF-08642534) with and without itraconazole. The total planned time of participation is about 12 weeks. The study consists of: * a screening period of up to 28 days before taking study drug * about 4 weeks of staying in the study clinic * a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time.
Key Dates
- Start date
- May 5, 2026
- Status verified
- May 2026
- Primary completion
- Jun 26, 2026
- Completion
- Jul 23, 2026
Study Design
- Enrollment
- 14 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Period 1--PF-08642534Participants will receive a single dose of PF-08642534
- Experimental: Period 2--itraconazole plus PF-08642534Participants will receive single doses of PF-08642534) in presence of itraconazole.
Primary Outcome Measure
PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 to 240 hours post-dose ]
Central Contacts
- Pfizer CT.gov Call Center1-800-718-1021
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | - |