Mass Balance Study of KBP-5074 in Healthy Male Subjects

NCT04634812 | Completed Phase 1 FDA Drug

• 1 other identifier: KBP5074-1-007
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Male Subjects; KBP-5074

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Metabolite radioprofiling and identification in plasma, urine and feces

  up to 240 hours postdose

Study Arms (1)

[14C]-KBP-5074

EXPERIMENTAL

Drug: KBP-5074

Interventions

KBP-5074 DRUG

a single oral dose of \[14C\]-KBP-5074

[14C]-KBP-5074

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KBP Biosciences: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

KBP-5074

Study Officials

• James McCabe

  KBP Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: December 3, 2020
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)