Phase 1
Completed N=6
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Source: ClinicalTrials.gov NCT03507569 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773
Summary
This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773 |
— | — |
| PRIMARY Plasma Concentrations of RO7017773 |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
2; 0; 1; 1 | — |
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 chemisty, serology, and urinalysis), as judged by the Investigator.
- Males 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 CNS infections
- Clinically significant abnormal finding from the MRI performed after the initial screening examination
- Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
- Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm
- History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment
Data sourced from ClinicalTrials.gov (NCT03507569). 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.