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

Registration

Registration

NCT06809608

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

36

Start

2025-02-13

Primary completion

2025-05-28

Lead sponsor

Hoffmann-La Roche

Conditions

Healthy Participants

Interventions

DRUG:RO7795081; DRUG:Itraconazole; DRUG:Gemfibrozil; DRUG:Cyclosporine

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

REGISTRY:2024-517360-37-00

Registered primary outcomes

• Part 1: Maximum Concentration Observed (Cmax) of RO7795081, Administered Alone and in Combination with Itraconazole [Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26]
• Part 1: Time to Maximum Concentration Observed (Tmax) of RO7795081, Administered Alone and in Combination with Itraconazole [Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26]
• Part 1: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081, Administered Alone and in Combination with Itraconazole [Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26]
• Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of RO7795081, Administered Alone and in Combination with Itraconazole [Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26]
• Part 2: Cmax of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine [Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18]
• Part 2: Tmax of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine [Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18]
• Part 2: AUClast of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine [Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18]
• Part 2: AUCinf of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine [Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18]