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

Phase 1

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: RO7017773; Other: [11C] Ro15-4513

• Registration Number: NCT03507569
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study Start: 2018-04-24
• Study First Posted: 2018-04-25
• Primary Completion: 2018-06-22
• Study Completion: 2018-06-22
• Results First Submitted: 2019-06-21
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-30
• Last Update Submitted: 2019-08-30
• Results First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RO7017773	RO7017773	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.
RO7017773	[11C] Ro15-4513	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.

Primary Outcome Measures

Name	Time	Method
Plasma Concentrations of RO7017773	Baseline up to 48 hrs
Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773	Baseline up to 48 hours (hrs)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	From treatment initiation until 14 days after the last dose of study treatment.

Trial Locations

Locations (1)

Hammersmith Medicines Research; Central Middlesex Hospital; 🇬🇧 London, United Kingdom