A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

October 24, 2017 updated by: BioCryst Pharmaceuticals

A Phase 1 Study to Evaluate the Effect of BCX7353 on the Single Dose Pharmacokinetics of the P-gp Substrate Digoxin and the BCRP Substrate Rosuvastatin and the Effect of the P-gp Inhibitor Cyclosporine on the Single Dose Pharmacokinetics of BCX7353

This is an open-label, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, open-label, fixed-sequence, drug interaction study to evaluate the effect of BCX7353 on the pharmacokinetics of the P-gp substrate digoxin and the BCRP substrate rosuvastatin, as well as the effect of the P-gp inhibitor cyclosporine on the pharmacokinetics of BCX7353.

It is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. Cohort 1 will evaluate the effects of multiple doses of BCX7353 on single-dose pharmacokinetics of digoxin. Cohort 2 will evaluate the effect of multiple doses of BCX7353 on the pharmacokinetics of rosuvastatin. Cohort 3 will evaluate the effect of a single dose of cyclosporine on the pharmacokinetics of BCX7353. Cohorts may be dosed in parallel or in any order.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • written informed consent
  • acceptable birth control measures for male subjects and women of childbearing potential
  • creatinine clearance of at least 80 mL/min by Cockcroft-Gault equation
  • complies with all required study procedures and restrictions

Key Exclusion Criteria:

  • clinically significant medical history, current medical or psychiatric condition
  • clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
  • current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1
  • use of medication that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing
  • participation in any other investigational drug study within 90 days of screening
  • recent or current history of alcohol or drug abuse
  • regular recent use of tobacco or nicotine products
  • positive serology for HBV, HCV, or HIV
  • pregnant or nursing
  • donation or loss of greater than 400 mL of blood within the previous 3 months
  • history of severe hypersensitivity to any medicinal product
  • for subjects enrolled in cohort 1, current use of antibiotics or probiotics, or use within 6 months prior to Day 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Day 1: Digoxin 0.25 mg oral dose Day 11-18: BCX7353 350 mg oral dose Day 19: Digoxin 0.25 mg oral dose and BCX7353 350 mg oral dose Day 20-21: BCX7353 350 mg oral dose
Drug: BCX7353
Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3
Drug: Digoxin
Day 1 of Cohort 1
Drug: BCX7353 + digoxin
Day 19 of Cohort 1
Experimental: Cohort 2
Day 1: Rosuvastatin 10 mg oral dose Day 7-14: BCX7353 350 mg oral dose Day 15: Rosuvastatin 10 mg oral dose and BCX7353 350 mg oral dose Day 16: BCX7353 350 mg oral dose
Drug: BCX7353
Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3
Drug: Rosuvastatin
Day 1 of Cohort 2
Drug: rosuvastatin + BCX7353
Day 15 of Cohort 1
Experimental: Cohort 3
Day 1: BCX7353 350 mg oral dose Day 14: single oral dose of Cyclosporine 600 mg and BCX7353 350 mg
Drug: BCX7353
Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3
Drug: Cyclosporine + BCX7353
Day 14 of Cohort 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of probe substrate
Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
AUClast of probe substrate
Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
AUCinf of probe substrate
Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: absolute and change from baseline through end of study, approximately 30 days
absolute and change from baseline through end of study, approximately 30 days
laboratory analyses
Time Frame: absolute and change from baseline through end of study, approximately 30 days
absolute and change from baseline through end of study, approximately 30 days
vital signs
Time Frame: absolute and change from baseline through end of study, approximately 30 days
absolute and change from baseline through end of study, approximately 30 days
physical examination findings
Time Frame: absolute and change from baseline through end of study, approximately 30 days
absolute and change from baseline through end of study, approximately 30 days
electrocardiograms
Time Frame: absolute and change from baseline throughend of study, approximately 30 days
absolute and change from baseline throughend of study, approximately 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Investigators

  • Principal Investigator: Firas Almazedi, MBChB, Msc, CPI, Covance Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX7353-105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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