Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06809608
PHASE1

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-02-13

Completion Date

2025-05-28

Last Updated

2026-09-28

Healthy Volunteers

Yes

Interventions

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).

Locations (1)

ICON

Groningen, Netherlands