Major depressive disorder mental disorder
Conditions
Interventions
The volunteer will receive a single dose of 0.16 mg/kg of 14C radioactively
labeled MIJ821. This means that 0.16 milligram of MIJ821 will be administered
per 1 kg of body weight, so the actual dose
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Healthy males, aged 18 to 55 years (inclusive) and in good health as determined by past and current medical history, physical and neurological examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline (whenever applicable). 3. At screening and at baseline (Day -1), vital signs after 5 minutes in supine position must be within the ranges defined in protocol inclusion criteria. 4. Participants must weigh at least 60 kg and should not exceed 90 kg to participate in the study and must have a body mass index (BMI) within the range of 18.0 to 29.9 kg/m² (inclusive) at screening. 5. NM or IM for CYP2D6. 6. Participants must be able to communicate well with the Investigator and to comply with the requirements of the entire study, including adhering to study restrictions and visit schedule. See protocol for complete details of inclusion criteria.
Exclusion criteria
Exclusion criteria: 1. Recent history (500 ng/mL at Screening or Baseline. 2. Positive blood alcohol concentration or drug test at Screening or Baseline. 3. Absence of regular defecation pattern (participants with an average defecation frequency of less than once per 2 days or chronic diarrhea). 4. Any surgical or medical condition that might significantly alter the (A)DME of drugs, or that may jeopardize the participant in case of participation in the study. 5. Exposure to radiation at a level of up to 1.0 mSv over the past year, or up to 3.0 mSv over the past 3 years. (e.g., due to systemic administration of radioactive substances, or to external irradiation [e.g., by X-rays] for diagnostic, therapeutic, job-related, or research purposes). Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine the routes and rates of excretion of [14C]MIJ821 related radioactivity, including mass balance of total drug-related radioactivity in urine, feces, and elimination of radioactivity via expired air, following a single 0.16 mg/kg 40-minute i.v. infusion of [14C]MIJ821 in healthy male participants. - To determine the pharmacokinetics (PK) of total radioactivity radiolabeled components in blood and plasma following a single 0.16 mg/kg 40-minute i.v. infusion of [14C]MIJ821 in healthy male participants. - To characterize the PK of MIJ821 and known key metabolites, if applicable, in plasma following a single 0.16 mg/kg 40-minute i.v. infusion of [14C]MIJ821 in healthy male participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of a single 0.16 mg/kg i.v. dose of [14C]MIJ821 in healthy male participants. | — |
Countries
Netherlands
Outcome results
None listed