A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
- Registration Number
- NCT03717064
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The main purpose of the study is to characterize the interaction between RO7049389 and the cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no intended clinical benefit to this study. The total duration of the study for each participant is approximately 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pitavastatin RO7049389 Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days. Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4. Pitavastatin Pitavastatin Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days. Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4.
- Primary Outcome Measures
Name Time Method Period 1: Apparent Total Clearance (CL/F) of Pitavastatin Period 1 Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin Period 1 Day 1 Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin Period 1 Day 1 Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin Period 2 Day 4 Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin Period 1 Day 1 Period 1: Elimination Half-Life (T1/2) of Pitavastatin Period 1 Day 1 Period 1: Volume of Distribution (V/F) of Pitavastatin Period 1 Day 1 Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin Period 2 Day 4 Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin Period 2 Day 4 Period 2: Apparent Total Clearance (CL/F) of Pitavastatin Period 2 Day 4 Period 2: Volume of Distribution (V/F) of Pitavastatin Period 2 Day 4 Period 2: Elimination Half-Life (T1/2) of Pitavastatin Period 2 Day 4
- Secondary Outcome Measures
Name Time Method Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin Period 1 Day 1 Period 2: Cmax of Pitavastatin Lactone Period 2 Day 4 Period 2: AUC0-inf of Pitavastatin Lactone Period 2 Day 4 Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin Period 2 Day 4 Period 2: Cmax of RO7049389 Period 2 Days 3-4 Percentage of Participants With Adverse Events (AEs) From the start of Period 1 through safety follow-up (Period 2, Day 34) An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Period 2: AUC-tau of RO7049389 Period 2 Days 3-4 Period 1: Cmax of Pitavastatin Lactone Period 1 Day 1 Period 1: AUC0-inf of Pitavastatin Lactone Period 1 Day 1
Trial Locations
- Locations (1)
Covance Research Unit - Daytona
🇺🇸Daytona Beach, Florida, United States