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
Active Not Recruiting

Conditions

  • Healthy Participant

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • PF-08642534 — DRUG
    Participants will receive a single dose of PF-08642534
  • Itraconazole — DRUG
    Participants 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

First listed
May 8, 2026
Start date
May 5, 2026
Status verified
Jun 2026
Primary completion
Jun 26, 2026
Completion
Jul 23, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Period 1--PF-08642534
    Participants will receive a single dose of PF-08642534
  • Experimental: Period 2--itraconazole plus PF-08642534
    Participants 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
New Haven Clinical Research UnitNew HavenConnecticut06511-

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New Haven Clinical Research Unit· New Haven, CT