Mass Balance Study of KBP-5074 in Healthy Male Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634812
• Other study ID #: KBP5074-1-007
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2020
• Est. completion date: December 23, 2020

Study information

• Verified date: February 2024
• Source: KBP Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• KBP-5074
a single oral dose of [14C]-KBP-5074

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
KBP Biosciences	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-8)	Area under the concentration-time curve from time 0 to infinity (AUC0-8) - Plasma	up to 216 hours postdose
Primary	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
Primary	Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)	Time of the maximum observed concentration (Cmax) - Plasma	up to 216 hours postdose
Secondary	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