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

NCT04606537 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-16

No results posted yet for this study

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

Interventions

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

Rifampin

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • KBP Biosciences

    lead INDUSTRY

Principal Investigators

  • James McCabe · KBP Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-24
Primary Completion
2020-11-30
Completion
2020-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04606537 on ClinicalTrials.gov