A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

NCT03136237 | Completed Phase 1

• 1 other identifier: BCX7353-105
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hereditary Angioedema

Outcome Measures

Primary Outcomes (3)

• Cmax of probe substrate

  plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period

• AUClast of probe substrate

  plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period

• AUCinf of probe substrate

  plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period

Secondary Outcomes (5)

• adverse events

  absolute and change from baseline through end of study, approximately 30 days

• laboratory analyses

  absolute and change from baseline through end of study, approximately 30 days

• vital signs

  absolute and change from baseline through end of study, approximately 30 days

• physical examination findings

  absolute and change from baseline through end of study, approximately 30 days

• electrocardiograms

  absolute and change from baseline throughend of study, approximately 30 days

Study Arms (3)

Cohort 1

EXPERIMENTAL

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; Drug: Digoxin; Drug: BCX7353 + digoxin

Cohort 2

EXPERIMENTAL

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; Drug: Rosuvastatin; Drug: rosuvastatin + BCX7353

Cohort 3

EXPERIMENTAL

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

Drug: BCX7353; Drug: Cyclosporine + BCX7353

Interventions

BCX7353 DRUG

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

Cohort 1; Cohort 2; Cohort 3

Digoxin DRUG

Day 1 of Cohort 1

Cohort 1

BCX7353 + digoxin DRUG

Day 19 of Cohort 1

Cohort 1

Rosuvastatin DRUG

Day 1 of Cohort 2

Cohort 2

rosuvastatin + BCX7353 DRUG

Day 15 of Cohort 1

Cohort 2

Cyclosporine + BCX7353 DRUG

Day 14 of Cohort 3

Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (1)

Covance CRU

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

berotralstat; Digoxin; Rosuvastatin Calcium; Cyclosporine

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Firas Almazedi, MBChB, Msc, CPI

  Covance Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 parallel treatment assessments

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 2, 2017
• Study Start: February 17, 2017
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

GB (1)