A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.
NCT Number: NCT06541678
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Danuglipron|DRUG: Cyclosporine|DRUG: Itraconazole
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2024-10-28
Locations: Pfizer Clinical Research Unit - Brussels, Bruxelles, Bruxelles-Capitale, Belgium

Summary:
The purpose of this study is to see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants. The information from this study may inform how danuglipron will be used in the future with medicines like cyclosporine and itraconazole.

Primary Outcome Measures: AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants., AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time

AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration., 0 to 72 hour postdose|Cmax: to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants., Maximum observed plasma concentration, 0 to 72 hour postdose|AUCinf (if data permits otherwise AUClast): to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants., AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time

AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration., 0 to 72 hour postdose|Cmax: to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants., Maximum observed plasma concentration, 0 to 72 hour postdose
Secondary Outcome Measures: Number of Participants With Treatment Emergent Adverse Events Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine, Day 1 up to approximately Day 47|Number of Participants With Clinical Laboratory Abnormalities Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine, Day 1 up to approximately Day 47|Number of Participants With Clinically Significant Change from Baseline Vital Signs Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine, Day 1 up to approximately Day 47|Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine, Day 1 up to approximately Day 47