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

Completed · Phase 1

Conditions studied: Healthy, Drug Drug Interaction

In brief

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.

Key facts

Study ID

NCT04606537

Run by

KBP Biosciences

People needed

24

Starts

2020-10-24

Expected to finish

2020-11-30

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• QPS Missouri — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.