A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.

NCT07575945 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C6601002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participant

Outcome Measures

Primary Outcomes (1)

• PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0 to 240 hours post-dose

Secondary Outcomes (1)

• Incidence of treatment-emergent Adverse Events

  Baseline up to approximately 8 weeks

Study Arms (2)

Period 1--PF-08642534

EXPERIMENTAL

Participants will receive a single dose of PF-08642534

Drug: PF-08642534

Period 2--itraconazole plus PF-08642534

EXPERIMENTAL

Participants will receive single doses of PF-08642534) in presence of itraconazole.

Drug: PF-08642534; Drug: Itraconazole

Interventions

PF-08642534 DRUG

Participants will receive a single dose of PF-08642534

Period 1--PF-08642534; Period 2--itraconazole plus PF-08642534

Itraconazole DRUG

Participants will receive itraconazole once daily for 13 days (Day 12 to Day 24)

Period 2--itraconazole plus PF-08642534

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG).
• Body Mass Index (BMI) of 16-30 kilograms per meter squared, inclusive, and a total body weight greater than 50 kilograms (110 pounds).

You may not qualify if:

• Evidence or history of clinically significant disease
• Specified abnormalities in safety assessments at Screening

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): July 23, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)