Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513

Roche

Status and phase: Completed; Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Drug: RO7017773; Other: [11C] Ro15-4513

Study type: Interventional

Funder types: Industry

Identifiers

NCT03507569

BP40257

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 23 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

RO7017773

Experimental group

Description:

The first two participants of the first cohort are anticipated to receive a single dose of RO7017773 orally. The doses to be tested in the subsequent cohorts of participants will be determined by review of PET scan, PK, and safety results from the previous dose level.

Treatment:

Other: [11C] Ro15-4513

Drug: RO7017773