A Study to Detect Radioactivity of [14C]-OPC-167832 in Urine and Feces in Healthy Men

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C]-OPC-167832

Study type: Interventional

Funder types: Industry

Identifiers

NCT07314320

323-201-00002

Details and patient eligibility

About

The purpose of this study is to determine the relative amounts of radioactivity excreted in urine and feces following a single oral dose of [14C]-OPC-167832 in healthy male participants.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m^2) (inclusive).

2. In good health as determined by:

   1. Medical history
   2. Physical examination
   3. ECG
   4. Serum/urine biochemistry, hematology, and serology tests.

3. Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.

4. Agree to remain exclusively in the research unit for the defined period.

5. Agree to comply with the protocol restrictions and requirements.

6. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

7. Male participants and their female partners who commit to remaining abstinent from trial screening through 90 days after the dose of investigational medicinal product (IMP) or utilizing 2 different approved methods of birth control from trial screening through 90 days after the dose of IMP.

8. Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP.

Exclusion criteria

1. Clinically relevant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including distribution, metabolism, and excretion of drug.
2. History of drug and/or alcohol abuse within 2 years prior to screening.
3. History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
4. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.
5. Participants having taken OPC-167832 within 30 days prior to screening.
6. Participants having 5 half-lives or twice the duration of the biological effect, whichever is longer, of any IMP (inclusive of OPC-167832) within 30 days prior to screening.
7. Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.
8. Any participant who, in the opinion of the investigator, should not participate in the trial.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

[14C]-OPC-167832

Experimental group

Description:

Participants receive a single dose of \[14C\]-OPC-167832, orally, on Day 1.

Treatment:

Drug: [14C]-OPC-167832