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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-17

Study Completion Date

2019-03-14

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RO7017773

Single dose of RO7017773

Group Type EXPERIMENTAL

RO7017773

Intervention Type DRUG

Single doses of RO7017773

RO7017773 and Itraconazole

Single dose of RO7017773 and multiple doses of itraconazole

Group Type EXPERIMENTAL

RO7017773

Intervention Type DRUG

Single doses of RO7017773

Itraconazole

Intervention Type DRUG

Multiple doses of Itraconazole

Interventions

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RO7017773

Single doses of RO7017773

Intervention Type DRUG

Itraconazole

Multiple doses of Itraconazole

Intervention Type DRUG

Other Intervention Names

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Sporanox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes