Healthy
Conditions
Keywords
Healthy Male Subjects, KBP-5074
Brief summary
This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
Interventions
DRUGKBP-5074
a single oral dose of \[14C\]-KBP-5074
Sponsors
Covance
KBP Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: 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: Time of the maximum observed concentration (Cmax) | up to 216 hours postdose | Time of the maximum observed concentration (Cmax) - Plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed