A study to evaluate the safety, tolerability, processing by the body and mechanism of action of multiple doses of ralmitaront with a single dose of risperidone administered to healthy participants
- Conditions
- Safety, tolerability, pharmacokinetics and pharmacodynamics of ralmitaront and risperidone in healthy participantsNot Applicable
- Registration Number
- ISRCTN14984258
- Lead Sponsor
- Roche (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
1. A body mass index (BMI) between 18–30 kg/m², inclusive, at screening
2. Fluent in English
1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, or cancer
2. Disorders of the CNS that are clinically significant as determined by the Investigator, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson’s, parkinsonism, and seizures
3. Elevated risk of clinically significant suicidal ideation and/or behavior within 2 years prior to screening as determined by the C-SSRS
4. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. Uncomplicated appendectomy and cholecystectomy are acceptable
5. A history of clinically significant hypersensitivity (e.g. drugs, excipients) or allergic reactions
6. Hypersensitivity to risperidone or paliperidone, as stated in the prescribing information for risperidone
7. In the opinion of the Investigator, any major illness within 1 month before the screening examination, or any febrile illness within 1 week prior to screening and up to first study treatment administration
8. Use of prohibited medications (vaccines, over-the-counter [OTC] or prescription medication including herbal medications) taken within 14 days (or 5 times the elimination half-life of the medication, whichever is longer) prior to dosing, with the exception of acetaminophen up to 2 g per day, which is allowed up to 48 hours before dosing, and stable hormonal replacement or contraception therapy; COVID vaccine must be at least 21 days before dosing
9. Use of any drug or herbal inducers of CYP3A, CYP2C19, CYP2D6, or Pgp within 28 days prior to dosing
10. Participants likely to need concomitant medication during the study period (including for dental conditions)
11. Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse in the last 5 years
12. Positive alcohol breath test or urine drug screen at screening or admission to the study site
13. Smokers who regularly smoke more than 5 cigarettes daily or equivalent and are unable or unwilling not to smoke during the confinement in CRU
14. Positive test result for human immunodeficiency virus (HIV) 1 and HIV 2, hepatitis C virus (HCV) antibody, or hepatitis B surface antigen (HBsAg)
15. Dietary restrictions that would prohibit the consumption of standardized meals
16. Participants under judicial supervision, guardianship, or curatorship
17. Women who are lactating
18. History of clinically significant back pain, back pathology, and/or back injury (e.g., degenerative disease, spinal deformity, spinal surgery, lumbar radiculopathy, chronic/recurrent headaches, intracranial tumors, and/or increase intracranial pressure) that may predispose to complications from, or technical difficulty with, a lumbar puncture
19. Criteria that would preclude a lumbar puncture, such as a local infection at the site of the lumbar puncture; clinically significant coagulation parameter abnormalities, thrombocytopenia, or treatment with an anticoagulant or with antiplatelet agents with
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method