Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects
Phase 1
Completed
- Conditions
- Drug Drug InteractionHealthy
- Interventions
- Registration Number
- NCT04606537
- Lead Sponsor
- KBP Biosciences
- Brief Summary
Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4 inducer (Cohort 2, rifampin multiple dose) on the plasma PK of a single dose of KBP-5074 in healthy male and female subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Males or females, of any race, between 18 and 60 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, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations
Exclusion Criteria
- Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
- Use of any drugs or substances known to be strong or moderate inhibitors or inducers of CYP3A4 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 (Effects of CYP3A4 induction on KBP-5074) KBP-5074 - Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074) KBP-5074 - Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074) Itraconazole - Cohort 2 (Effects of CYP3A4 induction on KBP-5074) Rifampin -
- Primary Outcome Measures
Name Time Method Pharmacokinetic Parameter: Maximum observed concentration (Cmax) Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose. Maximum observed concentration (Cmax) - Plasma
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 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-∞) Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose. Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QPS Missouri
🇺🇸Springfield, Missouri, United States