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A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

NCT ID: NCT03136237

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2017-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hereditary Angioedema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 parallel treatment assessments
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

BCX7353

Intervention Type DRUG

Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3

Digoxin

Intervention Type DRUG

Day 1 of Cohort 1

BCX7353 + digoxin

Intervention Type DRUG

Day 19 of Cohort 1

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

Group Type EXPERIMENTAL

BCX7353

Intervention Type DRUG

Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3

Rosuvastatin

Intervention Type DRUG

Day 1 of Cohort 2

rosuvastatin + BCX7353

Intervention Type DRUG

Day 15 of Cohort 1

Cohort 3

Day 1: BCX7353 350 mg oral dose Day 14: single oral dose of Cyclosporine 600 mg and BCX7353 350 mg

Group Type EXPERIMENTAL

BCX7353

Intervention Type DRUG

Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3

Cyclosporine + BCX7353

Intervention Type DRUG

Day 14 of Cohort 3

Interventions

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BCX7353

Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3

Intervention Type DRUG

Digoxin

Day 1 of Cohort 1

Intervention Type DRUG

BCX7353 + digoxin

Day 19 of Cohort 1

Intervention Type DRUG

Rosuvastatin

Day 1 of Cohort 2

Intervention Type DRUG

rosuvastatin + BCX7353

Day 15 of Cohort 1

Intervention Type DRUG

Cyclosporine + BCX7353

Day 14 of Cohort 3

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Firas Almazedi, MBChB, Msc, CPI

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical

Locations

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Covance CRU

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BCX7353-105

Identifier Type: -

Identifier Source: org_study_id