Skip to main content
OpenTrials
Completed

NCT Number: NCT04606537

Drug to Drug Interaction Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Drug Drug Interaction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS Missouri

Springfield, Missouri, 65802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Rifampin

Drug

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

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

Primary outcomes

  1. Pharmacokinetic Parameter: Maximum observed concentration (Cmax)

    Time frame: 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

  2. Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)

    Time frame: 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

  3. Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

KBP Biosciences

Industry

Collaborators

  • Covance

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2020
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.