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RECRUITING
NCT06982131
PHASE1

A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.

Official title: A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-06-04

Completion Date

2026-12-04

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

DRUG

RO7795081

RO7795081 will be administered orally during Periods 3, 4, and 5, according to the protocol.

DRUG

Placebo

Placebo will be administered orally during Periods 3, 4, and 5, according to the protocol.

DRUG

Rosuvastatin

A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4.

DRUG

Pitavastatin

A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5.

Locations (1)

ICON Plc (LPRA) - Netherlands

Groningen, Netherlands