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

Detailed criteria

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

Drug
14C-SEP-380135
Oral Capsule

Location

Celerion, Inc.
Lincoln, Nebraska

A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions