CompletedPhase 1

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

United States8 participantsStarted 2023-11-20

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m\^2) (inclusive).
✓. In good health as determined by:
✓. Medical history
✓. Physical examination
✓. ECG
✓. Serum/urine biochemistry, hematology, and serology tests.
✓. Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.
✓. Agree to remain exclusively in the research unit for the defined period.

Exclusion criteria

✕. 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.
✕. History of drug and/or alcohol abuse within 2 years prior to screening.
✕. 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.
✕. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.
✕. Participants having taken OPC-167832 within 30 days prior to screening.
✕. 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.
✕. Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.
✕. Any participant who, in the opinion of the investigator, should not participate in the trial.

What they're measuring

Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)

Timeframe: Up to Day 31

Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)

Timeframe: Up to Day 31

Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)

Timeframe: Up to Day 31

Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)

Timeframe: Up to Day 31

Trial details

NCT IDNCT07314320

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-27

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m\^2) (inclusive).
✓. In good health as determined by:
✓. Medical history
✓. Physical examination
✓. ECG
✓. Serum/urine biochemistry, hematology, and serology tests.
✓. Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.
✓. Agree to remain exclusively in the research unit for the defined period.

Exclusion criteria

✕. 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.
✕. History of drug and/or alcohol abuse within 2 years prior to screening.
✕. 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.
✕. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.
✕. Participants having taken OPC-167832 within 30 days prior to screening.
✕. 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.
✕. Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.
✕. Any participant who, in the opinion of the investigator, should not participate in the trial.

What they're measuring

Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)

Timeframe: Up to Day 31

Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)

Timeframe: Up to Day 31

Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)

Timeframe: Up to Day 31

Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)

Timeframe: Up to Day 31