PET study to assess the distribution of RO7308480 in the brai

Phase 1

• Conditions: Social anxiety disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN71330683
• 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: 2023-02-10
• Last Update Posted: 19 December 2023
• Study Completion: 2024-06-27

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Participants aged 23- 55 years
2. Body mass index 18-32 kg/m²
3. In good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests
4. Able to communicate with study personnel
5. Reliable, willing, and likely to comply with the protocol
6. Willing to comply with the contraception requirements of the protocol
7. Consent to inform their GP of their participation in the study, and to enter their details into the over-volunteering database (TOPS).

Exclusion Criteria

1. Not healthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, MRI scan and laboratory safety tests of blood and urine);
2. Abuse of alcohol or drugs;
3. Serious reaction to any medicine;
4. Taken certain medicines (ones that could affect the breakdown of the study medicine or that affect the central nervous system or blood flow) during the 30 days before dosing; taken any medicine (except paracetamol), herbal remedies or dietary supplements during the 2 weeks before dosing; taken isotretinoin 2 years prior to screening;
5. History of ophthalmologic conditions that might affect the corneal surface (such as keratoconus, severe dry eye disease and/or corneal dystrophy); wear prescription contact lenses on a daily basis, unless they are not willing to switch to prescription glasses during the study, including the follow-up visit;
6. Have had any condition or operation that might affect the way the body absorbs medicines; have had any clinically significant disease; history of seizures or convulsion ‘fits’ (other than single benign febrile convulsion of childhood);
7. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of receptor occupancy
8. Tried to commit suicide or homicide, had suicidal or homicidal thoughts; mental illness might compromise consent;
9. Pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol — because of the potential risk to the unborn or breastfed baby;
10. Claustrophobia; any condition which would make it difficult to lie still for very long;
11. Metal in the body (eg pacemaker, mechanical heart valve, replacement hip joint, shrapnel); have worked as a metal worker, machinist or welder — due to increased risk from MRI scans
12. Exposure to ionising radiation as part of a research study, such that combined with the exposure from this study their effective dose in a 12 month period would exceed 10 mSv.
13. Unsatisfactory venous access or contraindication for arterial cannulation;
14. Participants who have donated ?500 mL of blood or blood products or had significant blood loss within 3 months prior to screening.
15. participants who use 5 or more cigarettes per day or equivalent amount of tobacco or nicotine products — because participants must be able comfortably to abstain from smoking during the study.
16. Alanine aminotransferase and total bilirubin above the upper limit of normal (ULN) (added 27/06/2023)

Criteria are designed to select healthy young participants, who are robust enough to recover quickly from any adverse effects of RO7308480.

Study & Design

• Study Type: Interventional
• Study Design: Not specified