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
| Registry | NCT03507569 |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; non randomized, single group, masking: none, treatment |
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| Enrollment | 6 (Actual) |
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| Sponsor | Hoffmann-La Roche (Industry) |
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| Conditions | Autism Spectrum Disorder |
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| Interventions | RO7017773, [11C] Ro15-4513 (Drug, other) |
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| Dates | start 2018-04-24, primary completion 2018-06-22, completion 2018-06-22, first posted 2018-04-25, last updated 2019-09-30 |
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| Locations | 1 site in United Kingdom |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| RO7017773 | Experimental | Drug: RO7017773; Other: [11C] Ro15-4513 | 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. |
- 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.
- [11C] Ro15-4513 (Other): At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer \[11C\]Ro15-4513.
+Outcome measures
Primary outcomes
- 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
- Number of Participants With Adverse Events (AEs) [From treatment initiation until 14 days after the last dose of study treatment.]
+Eligibility
Sex: All, ages: 23 Years to 55 Years, accepts healthy volunteers
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
+Posted results
Participant flow
| Milestone | RO7017773 - 15mg | RO7017773 - 30mg | RO7017773 - 75mg | RO7017773 - 375mg |
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| Started | 2 | 1 | 2 | 1 |
| Completed | 2 | 1 | 2 | 1 |
| Not completed | 0 | 0 | 0 | 0 |
Outcome results
- Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773 (Primary)
- Plasma Concentrations of RO7017773 (Primary)
- Number of Participants With Adverse Events (AEs) (Secondary), Number, Participants: RO7017773 - 15mg 2; RO7017773 - 30mg 0; RO7017773 - 75mg 1; RO7017773 - 375mg 1
Adverse events
Time frame: From treatment initiation until 14 days after the last dose of study treatment.
| Arm | Deaths | Serious adverse events | Other adverse events |
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| RO7017773 - 15mg | 0/2 (0.0%) | 0/2 (0.0%) | 2/2 (100.0%) |
| RO7017773 - 30mg | 0/1 (0.0%) | 0/1 (0.0%) | 0/1 (0.0%) |
| RO7017773 - 75mg | 0/2 (0.0%) | 0/2 (0.0%) | 1/2 (50.0%) |
| RO7017773 - 375mg | 0/1 (0.0%) | 0/1 (0.0%) | 1/1 (100.0%) |
Other adverse events by term
| Term | Organ system | RO7017773 - 15mg | RO7017773 - 30mg | RO7017773 - 75mg | RO7017773 - 375mg |
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| Catheter site pain | General disorders | 2/2 | 0/1 | 0/2 | 0/1 |
| Catheter site paraesthesia | General disorders | 1/2 | 0/1 | 0/2 | 0/1 |
| Back pain | Musculoskeletal and connective tissue disorders | 0/2 | 0/1 | 1/2 | 0/1 |
| Catheter site bruise | General disorders | 0/2 | 0/1 | 0/2 | 1/1 |
| Muscle contractions involuntary | Nervous system disorders | 0/2 | 0/1 | 0/2 | 1/1 |
| Nausea | Gastrointestinal disorders | 0/2 | 0/1 | 0/2 | 0/1 |
| Somnolence | Nervous system disorders | 0/2 | 0/1 | 0/2 | 1/1 |
+Locations (1)
| Facility | City | Country | Status |
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| Hammersmith Medicines Research; Central Middlesex Hospital | London | United Kingdom | |
+Study documents