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

NCT07160738 — Phase 1, Completed, 25 participants, Pfizer

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, TWO-COHORT, TWO-PERIOD, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE AND PROBENECID ON THE PHARMACOKINETICS OF SINGLE DOSE PF-07220060 ADMINISTERED UNDER THE FED CONDITION TO HEALTHY PARTICIPANTS

RegistryNCT07160738
StatusCompleted
PhasePhase 1
Study typeInterventional; non randomized, crossover, masking: none, treatment
Enrollment25 (Actual)
SponsorPfizer (Industry)
ConditionsHealthy Adults
InterventionsPF-07220060, Itraconazole, Probenecid (Drug)
Datesstart 2025-09-22, primary completion 2025-11-24, completion 2025-12-22, first posted 2025-09-08, last updated 2026-04-03
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Adults All trials of PF-07220060 All trials of Itraconazole

-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.

Expand all sections  ·  Collapse all

+Detailed description

This study is seeking participants who are:

1\. male and female aged 18 to 65 years and are healthy as confirmed by medical tests 2. with body mass index (BMI) of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (110 pounds).

The study will consist of 2 groups each containing 2 periods. In both groups, participants will receive a single dose of PF-07220060 in Period 1. In group 1 Period 2, itraconazole will be given once a day from Day 1 to Day 9. On the morning of Period 2 Day 4, a single dose of PF 07220060 will be taken by mouth immediately after itraconazole is taken by mouth. In group 2 Period 2, probenecid will be given 4 times a day from Day 1 to Day 9. On the morning of Period 2 Day 3, a single dose of PF 07220060 will be taken by mouth, immediately after probenecid is taken by mouth.

In both groups, PF-07220060 will be given by mouth about 30 minutes after a moderate fat standard calorie meal in Period 1. In cohort 1 Period 2, itraconazole will be given by mouth once a day from Day 1 to Day 9 about 30 minutes after a moderate fat standard calorie meal. On the morning of Period 2 Day 4, a single dose of PF 07220060 will be administered by mouth immediately after itraconazole administration. In cohort 2 Period 2, probenecid will be given by mouth 4 times a day (QID) with 6±2 hours intervals from Day 1 to Day 9 with or without food. On Period 2 Day 2, the last probenecid dose prior to the Day 3 first dose will be given under fasted condition. On the morning of Period 2 Day 3, after 10 hours fasting, \~30 min after a moderate fat standard calorie breakfast, a single dose of PF-07220060 will be administered by mouth, immediately after probenecid administration.

The study will look at the effect of multiple doses of itraconazole and probenecid on how the body processes a single oral dose of PF-07220060.

Participants will take part in this study for up to 78 days for group 1 and 77 days for group 2. Following period 1 and 2, they will undergo lab tests and blood samples will be collected after administration of PF-07220060. Participants will be discharged from the research unit at the end of period 2 following completion of all tests.

+Arms and interventions

ArmTypeInterventionsDescription
Cohort 1, Period 1: PF-07220060ExperimentalDrug: PF-07220060In Cohort 1, Period 1 participants will receive a single dose of PF-07220060 tablet given orally and administered with food on Day 1.
Cohort 1, Period 2: PF-07220060 and itraconazoleExperimentalDrug: PF-07220060; Drug: ItraconazoleIn 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
Cohort 2, Period 1: PF-07220060ExperimentalDrug: PF-07220060In Cohort 2, Period 1 participants will receive a single dose of PF-07220060 tablet given orally and administered with food on Day 1.
Cohort 2, Period 2: PF-07220060 probenecidExperimentalDrug: PF-07220060; Drug: ProbenecidIn 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.
  • PF-07220060 (Drug): Tablet given orally
  • Itraconazole (Drug): Capsule given orally
  • Probenecid (Drug): Tablet given orally

+Outcome measures

Primary outcomes

  • 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

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion

* 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.

Exclusion

* 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.

+Locations (1)

FacilityCityCountryStatus
Pfizer Clinical Research Unit - New HavenNew Haven, ConnecticutUnited States

+Investigators

  • Pfizer CT.gov Call Center, Study director, Pfizer