A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

• Status: Completed
• Trial end date: 2019-03-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria

• Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the Investigator.

• Male and women of non-childbearing potential (WONCBP)

Exclusion Criteria

• History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis)

• History of clinically significant hypersensitivity or allergic reactions

• Abnormal blood pressure

• Abnormal pulse rate

• History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities

• Positive test for drugs of abuse or alcohol

• Evidence of human immunodeficiency virus (HIV) infection

• Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result at screening or within 3 months prior to starting study treatment

• Participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period