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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606537
• Other study ID #: KBP5074-1-008
• Status: Completed
• Phase: Phase 1
• Start date: October 24, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2024
• Source: KBP Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Drug Interaction
• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	QPS Missouri	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
KBP Biosciences	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameter: Maximum observed concentration (Cmax)	Maximum observed concentration (Cmax) - Plasma	Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose.
Primary	Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-8)	Area under the concentration-time curve from time 0 to infinity (AUC0-8) - Plasma	Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose.
Primary	Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)	Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma	Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose.