A study to assess the brain occupancy following a single dose of RO7268489 in healthy participants

Phase 1

• Conditions: Healthy participants; Not Applicable

• Registration Number: ISRCTN36003543
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-23
• Last Update Posted: 4 September 2023
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Participants who are overtly healthy (defined by absence of evidence of any active or chronic disease).
2. Body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m²) inclusive.

Exclusion Criteria

1. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract (with the exception of uncomplicated appendectomy, cholecystectomy and hernia repair).
2. Confirmed (based on the average of 3 consecutive measurements) systolic blood pressure greater than 140 or less than 90 millimeters of mercury (mmHg) and diastolic blood pressure greater than 90 or less than 45 mmHg at screening
3. Confirmed (based on the average of 3 consecutive measurements) resting pulse rate greater than 90 or less than 40 beats per minute (BPM) at screening.
4. Participants who have a history of migraine.
5. Any clinically significant history of hypersensitivity (e.g., drugs, excipients) or allergic reactions.
6. Contradiction for arterial cannulation. Allen’s test indicating potential risk in placement of the arterial cannula.
7. Participation in an investigational drug or device study within 90 days prior to dosing, as calculated from the day of follow-up from the previous study or within 30 days as assessed by the investigator
8. Participation in an investigational drug study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months prior to dosing as calculated from the day of follow-up from the previous study
9. Participants who are pregnant, lactating, or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Brain Occupancy Assessed Using PET Tracer from Day 1 up to Day 55<br>2. Relationship Between Exposure of RO7268489 in Plasma and Brain Occupancy Assessed Using Plasma Samples and PET Tracer from Day 1 up to Day 55

Secondary Outcome Measures

Name	Time	Method
1. Number of Participants With Adverse Events Graded Using a 3-Point Scale (Mild, Moderate or Severe) from Screening up to Day 56<br>2. Number of Participants With Change in Suicide Risk Determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) from Screening up to Day 56<br>3. Number of Participants With Change in Neuropsychiatric Symptoms Scores as Determined by the Brief Psychiatric Rating Scale (BPRS) from Screening up to Day 56<br>4. Plasma PK Parameters Of RO7268489 Using Standard Non-Compartmental Methods from Day 1 up to Day 56<br>5. RO7268489-related Change on Pharmacodynamics (PD) Biomarker From Samples Collected at Pre-dose and Multiple Timepoints Post-dose up to Day 56<br>6. RO7268489-related Change From Baseline on PD Biomarker From Samples Collected at Pre-dose and Multiple Timepoints Post-dose up to Day 56