A single-center, open-label study to evaluate the distribution, metabolism, and excretion (DME) and pharmacokinetics of MIJ821 following a single intravenous (i.v.) infusion of [14C]MIJ821 in healthy male participants.
- Conditions
- Major depressive disordermental disorder10027946
- Registration Number
- NL-OMON51743
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
1. Recent history (<3 months) prior to screening of nicotine product use or a
urine cotinine level >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To determine the routes and rates of excretion of [14C]MIJ821 related<br /><br>radioactivity, including mass balance of total drug-related radioactivity in<br /><br>urine, feces, and elimination of radioactivity via expired air, following a<br /><br>single 0.16 mg/kg 40-minute i.v. infusion of [14C]MIJ821 in healthy male<br /><br>participants.<br /><br><br /><br>- To determine the pharmacokinetics (PK) of total radioactivity radiolabeled<br /><br>components in blood and plasma following a single 0.16 mg/kg 40-minute i.v.<br /><br>infusion of [14C]MIJ821 in healthy male participants.<br /><br><br /><br>- To characterize the PK of MIJ821 and known key metabolites, if applicable, in<br /><br>plasma following a single 0.16 mg/kg 40-minute i.v. infusion of [14C]MIJ821 in<br /><br>healthy male participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the safety and tolerability of a single 0.16 mg/kg i.v. dose of<br /><br>[14C]MIJ821 in healthy male participants.</p><br>