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

Healthy Volunteers Clinical Trial

Official title:

A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774576
• Other study ID #: BP40822
• Secondary ID: 2018-002889-40
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: April 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• RO7017773
Single doses of RO7017773
• Itraconazole
Multiple doses of Itraconazole

Locations

Country	Name	City	State
France	BIOTRIAL	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Concentration (Cmax) of RO7017773 in Plasma		Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)
Secondary	Percentage of Participants With Adverse Events (AEs)		12 weeks
Secondary	Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)	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.	From screening visit through Period 2 Day 11
Secondary	Cmax of Itraconazole in Plasma		Period 2