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.
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Incidence and Severity of Adverse Events
Timeframe: From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Clinical Laboratory Test Results
Timeframe: From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Vital Sign Assessments
Timeframe: From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Electrocardiogram Parameters
Timeframe: From the first dose of study treatment until the final visit (up to 111 days)
Maximum Plasma Concentration Observed (Cmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUClast) of Rosuvastatin, Administered Alone and in Combination with RO7795081
Reference Study ID Number: BP45800 https://forpatients.roche.com/
Timeframe: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
AUC from Time 0 to Infinity (AUCinf) of Rosuvastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Cmax of Pitavastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
Tmax of Pitavastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
AUClast of Pitavastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
AUCinf of Pitavastatin, Administered Alone and in Combination with RO7795081
Timeframe: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4