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

KBP Biosciences

Status and phase

Completed

Phase 1

Conditions

Healthy

Drug Drug Interaction

Treatments

Drug: KBP-5074

Drug: Itraconazole

Drug: Rifampin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04606537

KBP5074-1-008

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.