Back to resultsOpen Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
RO7017773
[11C] Ro15-4513
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
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
Sites / Locations
- Hammersmith Medicines Research; Central Middlesex Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RO7017773
Arm 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.
Outcomes
Primary Outcome Measures
Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773
Plasma Concentrations of RO7017773
Secondary Outcome Measures
Number of Participants With Adverse Events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03507569
Brief Title
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RO7017773
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
RO7017773
Intervention Description
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
Other
Intervention Name(s)
[11C] Ro15-4513
Intervention Description
At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.
Primary Outcome Measure Information:
Title
Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773
Time Frame
Baseline up to 48 hours (hrs)
Title
Plasma Concentrations of RO7017773
Time Frame
Baseline up to 48 hrs
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Time Frame
From treatment initiation until 14 days after the last dose of study treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hammersmith Medicines Research; Central Middlesex Hospital
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
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