Mass Balance Study of KBP-5074 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: KBP-5074

• Registration Number: NCT04634812
• Lead Sponsor: KBP Biosciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-18
• Study Start: 2020-12-03
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

1. Males, of any race, between 18 and 55 years of age, inclusive, at screening.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
3. 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).
4. History of a minimum of 1 bowel movement per day.

Exclusion Criteria

1. 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).
2. 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).
3. Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in.
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-KBP-5074	KBP-5074	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Metabolite radioprofiling and identification in plasma, urine and feces	up to 240 hours postdose	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.

Trial Locations

Locations (1)

Covance Clinical Research Unit Inc.; 🇺🇸 Madison, Wisconsin, United States