A Study to Learn About How the Study Medicines Called Itraconazole and Probenecid Change How the Body Processes PF-07220060

NCT07160738 | Recruiting Phase 1 FDA Drug

• 1 other identifier: C4391011
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see and learn the effect of multiple doses of a strong CYP3A4 inhibitor and a potent UGT2B7 inhibitor on the PK of PF-07220060.

Conditions

Healthy Adults

Keywords

probenecid; breast cancer; CDK4 inhibitor; itraconazole; PF-07220060; Drug-Drug Interaction (DDI)

Outcome Measures

Primary Outcomes (2)

• Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax)

  Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post PF-07220060 dose for Period 1; Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post PF-07220060 dose for Period 2

• Plasma PF-07220060 Area under the plasma concentration versus time curve (AUC)

  Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post PF-07220060 dose for Period 1; Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post PF-07220060 dose for Period 2

Secondary Outcomes (5)

• Number of Participants With Laboratory Abnormalities

  From baseline up to 28 to 35 days after last dose of investigational drug

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  From baseline up to 28 to 35 days after last dose of investigational drug

• Number of Participants With Treatment-Emergent Adverse Events (AEs)

  From baseline up to 28 to 35 days after last dose of investigational drug

• Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

  From baseline up to 28 to 35 days after last dose of investigational drug

• Number of participants taking concomitant medications

  From baseline up to 28 to 35 days after last dose of investigational drug

Study Arms (4)

Cohort 1, Period 1: PF-07220060

EXPERIMENTAL

In Cohort 1, Period 1 participants will receive a single dose of PF-07220060 tablet given orally and administered with food on Day 1.

Drug: PF-07220060

Cohort 1, Period 2: PF-07220060 and itraconazole

EXPERIMENTAL

In Cohort 1 Period 2, participants will receive oral dose of itraconazole once daily from Day 1 to Day 9. On the morning of Day 4, participants will first receive one oral dose of itraconazole followed by a single oral dose of PF-07220060 tablet

Drug: PF-07220060; Drug: Itraconazole

Cohort 2, Period 1: PF-07220060

EXPERIMENTAL

In Cohort 2, Period 1 participants will receive a single dose of PF-07220060 tablet given orally and administered with food on Day 1.

Drug: PF-07220060

Cohort 2, Period 2: PF-07220060 probenecid

EXPERIMENTAL

In Cohort 2, Period 2, participants will receive oral dose of probenecid four times a day from Day 1 to Day 9. On the morning of Day 3, participants will first receive one oral dose of probenecid followed by a single oral dose of PF-07220060 tablet.

Drug: PF-07220060; Drug: Probenecid

Interventions

PF-07220060 DRUG

Tablet given orally

Cohort 1, Period 1: PF-07220060; Cohort 1, Period 2: PF-07220060 and itraconazole; Cohort 2, Period 1: PF-07220060; Cohort 2, Period 2: PF-07220060 probenecid

Itraconazole DRUG

Capsule given orally

Cohort 1, Period 2: PF-07220060 and itraconazole

Probenecid DRUG

Tablet given orally

Cohort 2, Period 2: PF-07220060 probenecid

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
• Evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.

You may not qualify if:

• Evidence or history of blood dyscrasias, uric acid kidney stones, peptic ulcer or gout for probenecid cohort (Applicable to Cohort 2).
• Evidence or history of genetic deficiency of glucose -6- phosphate dehydrogenase in red blood cells for probenecid cohort (Applicable to Cohort 2).
• Concomitant use of any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 are prohibited within 5 half-lives plus 14 days (up to 28 days) prior to first dose of PF 07220060.
• Concomitant use of methotrexate, salicylates, penicillin or other beta-lactams, sulfonamide, ketamine, thiopental anesthesia, indomethacin, naproxen, ketoprofen, meclofenamate, lorazepam are prohibited within 5 half-lives plus 14 days (up to 28 days) prior to first dose of PF 07220060 (Applicable to Cohort 2).
• History of sensitivity to azole antifungals, probenecid, or any of the formulation components of PF-07220060.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Itraconazole; Probenecid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 22, 2025
• Primary Completion: December 18, 2025
• Study Completion: January 9, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)