NCT06541678

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.

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is seeking healthy participants who: * are aged 18 years of age or older. * are confirmed to be healthy by some medical tests. * both men and women can participate. Women who can produce a baby must agree to use a highly effective method of birth control. * have body mass index (BMI) of 16 to 32 kilograms per meter squared. * a total body weight of more than 50 kilograms. Participants will receive danuglipron tablet by mouth on Day 1. Then on Day 4, participants will take cyclosporine capsules and danuglipron tablet by mouth at the same time. From Day 7 of the study, participants will take itraconazole solution by mouth once a day until Day 12. On Day 10 of the study, danuglipron tablet will also be taken with itraconazole at the same time. The total planned time of participation is about 10 weeks. The study consists of: screening period of up to 28 days before taking sisunatovir. 13 days 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

Interventions

Type	Name	Description
DRUG	Danuglipron	MR Tablet
DRUG	Cyclosporine	Capsule
DRUG	Itraconazole	Oral solution

Timeline

• Start date: 2024-12-23
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2024-08-07
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study