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

Autism Spectrum Disorder Clinical Trial

Official title:

A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain alpha5-Containing GABAA Receptors of Ro7017773 Using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507569
• Other study ID #: BP40257
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2018
• Est. completion date: June 22, 2018

Study information

• Verified date: August 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Drug:
• 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.

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

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research; Central Middlesex Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773		Baseline up to 48 hours (hrs)
Primary	Plasma Concentrations of RO7017773		Baseline up to 48 hrs
Secondary	Number of Participants With Adverse Events (AEs)		From treatment initiation until 14 days after the last dose of study treatment.