Healthy ParticipantPhase 1NCT07575945
A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.
A Phase 1 study testing PF-08642534 and Itraconazole in people with Healthy Participant, run by Pfizer at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant
- What is being tested?
- PF-08642534 and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to 23 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Evidence or history of clinically significant disease
- Specified abnormalities in safety assessments at Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF PF-08642534 IN HEALTHY ADULT PARTICIPANTS
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:
Read more
- 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
- Being tested
- PF-08642534, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08642534Drug
Participants will receive a single dose of PF-08642534
ItraconazoleDrug
Participants will receive itraconazole once daily for 13 days (Day 12 to Day 24)
| Study group | Role | What they receive |
|---|---|---|
| Period 1--PF-08642534 | Experimental | Participants will receive a single dose of PF-08642534 Receives: Drug: PF-08642534 |
| Period 2--itraconazole plus PF-08642534 | Experimental | Participants will receive single doses of PF-08642534) in presence of itraconazole. Receives: Drug: PF-08642534; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0 to 240 hours post-dose
Secondary outcomes (1)
Incidence of treatment-emergent Adverse Events
Measured: Baseline up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start5 May 2026
- Primary completion26 Jun 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575945
- Sponsor's protocol ID
- C6601002
- Status last verified
- Aug 2026
- First submitted
- 4 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF PF-08642534 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07575945
- Acronym / sponsor ID
- C6601002
- Conditions
- Healthy Participant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 May 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1--PF-08642534 | Experimental | Drug: PF-08642534Participants will receive a single dose of PF-08642534 |
| Period 2--itraconazole plus PF-08642534 | Experimental | Drug: PF-08642534, Drug: ItraconazoleParticipants will receive single doses of PF-08642534) in presence of itraconazole. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant disease
- Specified abnormalities in safety assessments at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-08642534Participants will receive a single dose of PF-08642534 | Drug | Period 1--PF-08642534, Period 2--itraconazole plus PF-08642534 |
| ItraconazoleParticipants will receive itraconazole once daily for 13 days (Day 12 to Day 24) | Drug | Period 2--itraconazole plus PF-08642534 |
Primary outcome
PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0 to 240 hours post-dose
1 secondary outcome
Incidence of treatment-emergent Adverse Events
Time frame: Baseline up to approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-08642534 and Itraconazole in people with Healthy Participant, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.