Autism Spectrum DisorderPhase 1NCT03507569
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
A Phase 1 study testing RO7017773 and [11C] Ro15-4513 in people with Autism Spectrum Disorder, run by Hoffmann-La Roche at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 23 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- RO7017773 and [11C] Ro15-4513
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2018to 22 Jun 2018
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research; Central Middlesex Hospital
London, NW10 7EW
About this study
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
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
- Being tested
- RO7017773, [11C] Ro15-4513
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7017773Drug
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] Ro15-4513Other
At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: RO7017773; Other: [11C] Ro15-4513 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773
Measured: Baseline up to 48 hours (hrs)
Plasma Concentrations of RO7017773
Measured: Baseline up to 48 hrs
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs)
Measured: From treatment initiation until 14 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start24 Apr 2018
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507569
- Sponsor's protocol ID
- BP40257
- Status last verified
- Aug 2019
- First submitted
- 16 Apr 2018
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No