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

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteers

Interventions: RO7017773, Itraconazole

Countries: France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Rennes, France