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

NCT04606537 | Completed Phase 1 FDA Drug

• 1 other identifier: KBP5074-1-008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Drug Drug Interaction

Keywords

KBP5074; Healthy Subjects; itraconazole; rifampin

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074)

EXPERIMENTAL

Drug: Itraconazole; Drug: KBP-5074

Cohort 2 (Effects of CYP3A4 induction on KBP-5074)

EXPERIMENTAL

Drug: Rifampin; Drug: KBP-5074

Interventions

Itraconazole DRUG

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.

Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074)

Rifampin DRUG

600 mg rifampin, given orally as 2 × 300-mg capsules QD on Days 15 through 25, inclusive.

Cohort 2 (Effects of CYP3A4 induction on KBP-5074)

KBP-5074 DRUG

0.5 mg KBP-5074, given orally as 1 × 0.5-mg tablet on Days 1 and 19 or Days 1 and 21

Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074); Cohort 2 (Effects of CYP3A4 induction on KBP-5074)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KBP Biosciences: lead
• Covance: collaborator

Study Sites (1)

QPS Missouri

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Interventions

Itraconazole; Rifampin; KBP-5074

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• James McCabe

  KBP Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 28, 2020
• Study Start: October 24, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)