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

NCT03774576 | Completed Phase 1 Results

• 2 other identifiers: BP408222018-002889-40
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Maximum Concentration (Cmax) of RO7017773 in Plasma

  Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)

Secondary Outcomes (3)

• 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

• Cmax of Itraconazole in Plasma

  Period 2

Study Arms (2)

RO7017773

EXPERIMENTAL

Single dose of RO7017773

Drug: RO7017773

RO7017773 and Itraconazole

EXPERIMENTAL

Single dose of RO7017773 and multiple doses of itraconazole

Drug: RO7017773; Drug: Itraconazole

Interventions

RO7017773 DRUG

Single doses of RO7017773

RO7017773; RO7017773 and Itraconazole

Itraconazole DRUG

Multiple doses of Itraconazole

Also known as: Sporanox

RO7017773 and Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

BIOTRIAL

Rennes, 35042, France

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: December 17, 2018
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: May 7, 2020
• Results First Posted: May 7, 2020

Record last verified: 2020-04

Locations

FR (1)