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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: RO7017773; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03774576

BP40822

2018-002889-40 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

RO7017773

Experimental group

Description:

Single dose of RO7017773

Treatment:

Drug: RO7017773

RO7017773 and Itraconazole

Experimental group

Description:

Single dose of RO7017773 and multiple doses of itraconazole

Treatment:

Drug: Itraconazole

Drug: RO7017773