Clinical trial NCT04634812: Mass Balance Study of KBP-5074 in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Male Subjects
KBP-5074
Lead sponsor: KBP Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2020-11-18
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mass Balance of KBP-5074
timeFrame: up to 240 hours postdose
measure: Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
timeFrame: up to 216 hours postdose
measure: Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
timeFrame: up to 216 hours postdose
measure: Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)
timeFrame: up to 216 hours postdose
Secondary outcomes:
measure: Metabolite radioprofiling and identification in plasma, urine and feces
timeFrame: up to 240 hours postdose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit Inc.
state: Wisconsin
Study officials:
affiliation: KBP Biosciences
name: James McCabe
role: STUDY_DIRECTOR
References: