Phase 1
Completed N=14
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT03774576 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Maximum Concentration (Cmax) of RO7017773 in Plasma — 458; 516 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of RO7017773 in Plasma |
458; 516 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
57.1; 14.3; 53.8 | — |
| SECONDARY Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0 | — |
| SECONDARY Cmax of Itraconazole in Plasma |
724 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03774576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.