Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects

Phase 1, Open-label, Parallel, 2-arm, Fixed-sequence Study to Investigate the Effect of Coadministration of CYP3A4 Inhibitor and CYP3A4 Inducer on the Pharmacokinetics, Safety, and Tolerability of KBP-5074 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Drug Drug Interaction
• Intervention / Treatment: Drug: Itraconazole; Drug: KBP-5074; Drug: Rifampin

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • QPS Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074)	Drug: Itraconazole; 200 mg itraconazole, given orally as 20 mL × 10-mg/mL solution BID on Day 15, followed by QD dosing on Days 16 through 23, inclusive.; Drug: KBP-5074; 0.5 mg KBP-5074, given orally as 1 × 0.5-mg tablet on Days 1 and 19 or Days 1 and 21
Experimental: Cohort 2 (Effects of CYP3A4 induction on KBP-5074)	Drug: KBP-5074; 0.5 mg KBP-5074, given orally as 1 × 0.5-mg tablet on Days 1 and 19 or Days 1 and 21; Drug: Rifampin; 600 mg rifampin, given orally as 2 × 300-mg capsules QD on Days 15 through 25, inclusive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Parameter: Maximum observed concentration (Cmax)	Maximum observed concentration (Cmax) - Plasma	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.
Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)	Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma	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.
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	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.

Collaborators and Investigators

• Sponsor: KBP Biosciences
• Collaborators: Covance
• Investigators: Study Director: James McCabe, KBP Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Subjects; rifampin; itraconazole; KBP5074
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Rifamycins; Lactams, Macrocyclic; Macrocyclic Compounds; Triazoles; Piperazines; Rifampin; Itraconazole; KBP-5074
• Other Study ID Numbers: KBP5074-1-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No