NCT07314320CompletedPhase 1
A Phase 1, Open-Label, Single-Dose Trial to Evaluate the Mass Balance and Pharmacokinetics of [14C]-OPC-167832 Administered Orally in Healthy Male Subjects
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country8 target enrollmentStarted: November 20, 2023Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •Serum/urine biochemistry, hematology, and serology tests.
- •Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -
- •Agree to remain exclusively in the research unit for the defined period.
- •Agree to comply with the protocol restrictions and requirements.
- •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.
- •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.
- •Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP.
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.
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
Arms & Interventions
[14C]-OPC-167832
Experimental
Participants receive a single dose of [14C]-OPC-167832, orally, on Day 1.
Intervention: [14C]-OPC-167832 (Drug)
Outcomes
Primary Outcomes
Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)
Time Frame: Up to Day 31
Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)
Time Frame: Up to Day 31
Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)
Time Frame: Up to Day 31
Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)
Time Frame: Up to Day 31
Secondary Outcomes
- Maximum (peak) Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood(Up to Day 31)
- Time to Maximum (Peak) Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood(Up to Day 31)
- Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Observable Concentration (AUCt) of Total Radioactivity in Plasma and Whole Blood(Up to Day 31)
- Area Under the Concentration-Time Curve From Time Zero to infinity (AUCinfinity) of Total Radioactivity in Plasma and Whole Blood(Up to Day 31)
- Terminal-phase Elimination Half-life (t1/2,z) of Total Radioactivity in Plasma and Whole Blood(Up to Day 31)
- Hemocrit Blood to Plasma Concentration Adjusted Ratio(Up to Day 31)
- Percentage of Metabolite in Plasma With an AUC > 10% of the AUC of Plasma Radioactivity Based on Radiometric Profiling(Up to Day 31)
- Cmax of OPC-167832(Up to Day 31)
- Tmax of OPC-167832(Up to Day 31)
- AUCt of OPC-167832(Up to Day 31)
- AUCinfinity of OPC-167832(Up to Day 31)
- t1/2,z of OPC-167832(Up to Day 31)
- Apparent Clearance (CL/F) of Drug from Plasma Following Extravascular Administration of OPC-167832(Up to Day 31)
- Percent Radioactivity Excreted in Urine and Feces as Parent and Identified Metabolites From Profiling data(Up to Day 31)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to Day 31)
- Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests(Up to Day 31)
- Number of Participants With Potentially Clinically Relevant Changes in Vital Signs(Up to Day 31)
- Number of Participants With Potentially Clinically Relevant Changes in Physical Examinations(Up to Day 31)
- Number of Participants With Potentially Clinically Relevant Changes in Electrocardiogram (ECG) Parameters(Up to Day 31)
Investigators
Study Sites (1)
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