A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults
NCT05745701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2024-09-23
Summary
This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants.
The 3 study periods will be conducted consecutively without a break.
Conditions
- Healthy
Interventions
- DRUG
-
PF-07081532
Oral Tablet
- DEVICE
-
Cyclosporine
Oral Solution
- DRUG
-
Itraconazole
Oral Capsule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-22
- Primary Completion
- 2023-05-29
- Completion
- 2023-05-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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