NCT06809608

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081

An Open-Label, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Itraconazole, Multiple Oral Doses of Gemfibrozil, and Single Oral Dose of Cyclosporine, on the Pharmacokinetics of a Single Oral Dose of RO7795081 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants. Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on the pharmacokinetics (PK) of RO7795081 in healthy participants. A maximum of up to 25 participants will be enrolled in Part 1 and sequentially undergo Period 1 (RO7795081 alone) followed by Period 2 (RO7795081 with itraconazole). Part 2 of the study has an adaptive design with up to 4 periods (a single fixed sequence) and will investigate the impact of gemfibrozil and cyclosporine on the PK of RO7795081 in healthy participants. A maximum of up to 25 participants will be enrolled in Part 2 and sequentially undergo Period 1 (RO7795081 alone) followed by Period 2 (RO7795081 with gemfibrozil), Period 3 (RO7795081 with cyclosporine 200 mg), and finally Period 4 (RO7795081 with cyclosporine ≤600 mg).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	RO7795081	A single dose will be administered orally per study period (see arm descriptions).
DRUG	Itraconazole	Administered orally (see arm description).
DRUG	Gemfibrozil	Administered orally (see arm description).
DRUG	Cyclosporine	A single dose will be administered orally per study period (see arm descriptions).

Timeline

• Start date: 2025-02-13
• Primary completion: 2025-06-16
• Completion: 2025-06-16
• First posted: 2025-02-05
• Last updated: 2025-07-08

Locations

1 site across 1 country: Netherlands