Close
Close

An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates

Access Programs

Disease Information

Descriptive Information
Brief Title † An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
Official Title † A Single Sequence, Open-Label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 3A4, 2C9, 2C19 and 2D6 Enzyme Activity Using Probe Substrates in Healthy Subjects
Brief Summary This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of BCX7353.
Detailed Description This is a single centre, single sequence, open-label, study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 (CYP) 3A4 (midazolam IV and PO, respectively), CYP2C9 (tolbutamide), CYP2C19 (omeprazole) and CYP2D6 (dextromethorphan) enzyme activity using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of BCX7353. Twenty healthy male and female subjects are planned for dosing. Each subject will receive the following treatments: Day 1: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally. Day 2: a single oral dose of 2 mg midazolam. Days 3 to 9: 350 mg BCX7353 once a day. Day 10: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, 30 mg dextromethorphan and 350 mg BCX7353, orally. Day 11: a single oral dose of 2 mg of midazolam along with 350 mg BCX7353.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Cmax of probe substrates
Secondary Outcome Measure † adverse events
Condition † Hereditary Angioedema
Intervention † DrugBCX7353 and probes
Study Arms / Comparison Groups Metabolic Probes and BCX7353 Day 1: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally. Day 2: a single oral dose of 2 mg midazolam. Days 3 to 9: 350 mg BCX7353 once a day. Day 10: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, 30 mg dextromethorphan and 350 mg BCX7353, orally. Day 11: a single oral dose of 2 mg of midazolam along with 350 mg BCX7353.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 20
Start Date † March 2016
Completion Date June 2016
Primary Completion Date June 2016
Eligibility Criteria † Key Inclusion Criteria: - Written informed consent - Body mass index 18 to 32 kg/m2 - Abides by study restrictions - Attends all study visits and agrees to remain in study center for the confinement period - Acceptable birth control measures for male subjects and women of childbearing potential Key Exclusion Criteria: - Clinically significant medical history, current medical or psychiatric condition. This includes a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, or cardiac disease - Clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline - Poor or ultra- metabolizers of CYP2C19 or CYP2D6 Use of over the counter or prescription medication within 14 days of dosing and anticipated use through the follow-up visit - Use of medication or consumption of any substance 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 3 months - Serious adverse reaction or serious hypersensitivity to any drug
Gender All
Ages 18 Years - 55 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United Kingdom
Administrative Information
NCT ID † NCT02819102
Organization ID BCX7353-102
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † BioCryst Pharmaceuticals
Collaborators ††
Investigators † Principal Investigator: Litza McKenzie, MBChB, Quotient Clinical Ltd
Information Provided By
Verification Date June 2016
First Received Date † June 28, 2016
Last Updated Date January 30, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
Find a Clinical Trial
Related Videos
by Abidemi Uruejoma
279 views
by Abidemi Uruejoma
604 views
by Abidemi Uruejoma
602 views
by Abidemi Uruejoma
873 views
by Abidemi Uruejoma
4,500 views
Free Newsletter