Study to evaluate the safety, tolerability, and effect of the body and food on RO7308480 following oral administration in healthy participants
- Conditions
- Safety, tolerability, pharmacokinetics, and food effects of single-ascending oral doses of RO7308480 in healthy participantsNot Applicable
- Registration Number
- ISRCTN63295298
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 96
1. 18 to 55 years of age inclusive, at the time of signing the informed consent
2. Male and female participants who are overtly healthy (defined by the absence of evidence of any active or chronic disease) as determined by medical evaluation
3. Participants able to communicate with the study staff
4. Body mass index (BMI) of 18 to 30 kg/m² inclusive
1. Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study
2. Use of any psychoactive medication, or medications known to have effects on central nervous system (CNS) or blood flow taken within 4 weeks prior to first dosing
3. History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis)
4. Any major illness within one month before the screening examination (e.g., COVID-19 infection) or any febrile illness within 1 week prior to screening and up to first study drug administration
5. Clinically significant abnormalities in laboratory test results
6. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
7. Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk, or any participant with a history of suicidal or homicidal attempts
8. Participants likely to need concomitant medication during the study period
9. Use of isotretinoin within 2 years prior to screening
10. Incomplete SARS-CoV-2/COVID-19 vaccinations scheme 2 weeks prior to administration of the first dose
11. Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the day of follow-up from the previous study, or more than four times a year
12. Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
13. Positive result on hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening or within 3 months prior to starting study treatment
14. Any suspicion or history of alcohol abuse
15. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that contraindicates the participation in the study
16. Participants who regularly smoke more than 5 cigarettes daily or equivalent amount of tobacco and nicotine substitutes as determined by history, and unable or unwilling not to smoke during the in-house period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method