A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults
Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.
Eligibility
- Age range
- 18–55 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²). 2. In good overall health, based on: 1. Medical history 2. Physical examination 3. Neurological examination 4. Vital signs 5. Electrocardiogram (ECG) 6. Blood and urine tests (serum chemistry, hematology, urinalysis, serology) 3. Regular daily bowel movements (at least one per day) for 30 days before Day -2. 4. Ability to provide written informed consent and follow all study instructions. 5. Has a stable living situation at screening and agrees to return to a similar livin…
Interventions
- Drug14C-SEP-380135
Oral Capsule
Location
- Celerion, Inc.Lincoln, Nebraska