Status:
COMPLETED
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03774576
Start Date
December 17 2018
End Date
March 14 2019
Last Update
May 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
BIOTRIAL
Rennes, France, 35042