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

NCT ID: NCT03507569

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2018-06-22

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RO7017773

Intervention Type: 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.

[11C] Ro15-4513

Intervention Type: OTHER

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

Interventions

RO7017773

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.

Intervention Type: DRUG

[11C] Ro15-4513

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hammersmith Medicines Research; Central Middlesex Hospital

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BP40257

Identifier Type: -

Identifier Source: org_study_id