NCT04606537

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: KBP Biosciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-10-24
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2020-10-28
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study