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

NCT03507569 | Completed Phase 1 Results

• 1 other identifier: BP40257
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773

  Baseline up to 48 hours (hrs)

• Plasma Concentrations of RO7017773

  Baseline up to 48 hrs

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  From treatment initiation until 14 days after the last dose of study treatment.

Study Arms (1)

RO7017773

EXPERIMENTAL

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.

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

Interventions

RO7017773 DRUG

RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.

RO7017773

[11C] Ro15-4513 OTHER

At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer \[11C\]Ro15-4513.

RO7017773

Eligibility Criteria

• Age: 23 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Hammersmith Medicines Research; Central Middlesex Hospital

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Ro 15-4513

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: April 24, 2018
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-08

Locations

GB (1)