NCT03717064

A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers

An Open-Label, Fixed Sequence, Two-Period Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RO7049389	RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.
DRUG	Pitavastatin	Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.

Timeline

• Start date: 2018-11-07
• Primary completion: 2018-12-17
• Completion: 2018-12-17
• First posted: 2018-10-24
• Last updated: 2020-01-10
• Results posted: 2020-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study