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

NCT ID: NCT04606537

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-24

Study Completion Date

2020-11-30

Brief Summary

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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

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Conditions

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Healthy Drug Drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Itraconazole

Intervention Type 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.

KBP-5074

Intervention Type 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 2 (Effects of CYP3A4 induction on KBP-5074)

Group Type EXPERIMENTAL

Rifampin

Intervention Type DRUG

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

KBP-5074

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Rifampin

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Covance

INDUSTRY

Sponsor Role collaborator

KBP Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James McCabe

Role: STUDY_DIRECTOR

KBP Biosciences

Locations

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QPS Missouri

Springfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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KBP5074-1-008

Identifier Type: -

Identifier Source: org_study_id