Mass Balance Study of KBP-5074 in Healthy Male Subjects

Study Overview
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Brief Summary
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This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.

Official Title
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A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: KBP-5074


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, of any race, between 18 and 55 years of age, inclusive, at screening. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. In good health, determined by no clinically significant findings from medical history, physical examination (assessed only at check-in), 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee). History of a minimum of 1 bowel movement per day. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, or other disorder, as determined by the investigator (or designee). History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed). Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in. Use of any drugs or substances known to be strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 or P-glycoprotein substrates within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-KBP-5074<br> | Drug: KBP-5074<br>* a single oral dose of [14C]-KBP-5074<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance of KBP-5074 | Percentage of total radioactivity recovered in urine and feces following a single dose [14C]-KBP-5074 | up to 240 hours postdose | 
| Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) | Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma | up to 216 hours postdose | 
| Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) | Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma | up to 216 hours postdose | 
| Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax) | Time of the maximum observed concentration (Cmax) - Plasma | up to 216 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite radioprofiling and identification in plasma, urine and feces | Select plasma, urine, and fecal samples will be processed and subject to metabolite analysis by LC/MS & LC/MS/MS using high-resolution mass spectrometry. | up to 240 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Male Subjects, KBP-5074