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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: RO7017773; Drug: Itraconazole

• Registration Number: NCT03774576
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Study Start: 2018-12-17
• Primary Completion: 2019-03-14
• Study Completion: 2019-03-14
• Results First Submitted: 2020-03-10
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Results First Posted: 2020-05-07
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RO7017773	RO7017773	Single dose of RO7017773
RO7017773 and Itraconazole	RO7017773	Single dose of RO7017773 and multiple doses of itraconazole
RO7017773 and Itraconazole	Itraconazole	Single dose of RO7017773 and multiple doses of itraconazole

Primary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of RO7017773 in Plasma	Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	12 weeks
Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)	From screening visit through Period 2 Day 11	The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present.
Cmax of Itraconazole in Plasma	Period 2

Trial Locations

Locations (1)

BIOTRIAL; 🇫🇷 Rennes, France