First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have in the body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BioCryst Pharmaceuticals
• Treatments: Berotralstat

Criteria

Key Inclusion Criteria:

• Written informed consent

• Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg

• 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

• Part 3 only: Japanese subjects enrolled in Part 3 must be first generation: born in Japan, not having lived outside Japan > 5 years, able to trace maternal and paternal Japanese ancestry, with no significant change in lifestyle, including diet (at least one Japanese meal consumed per day), since leaving Japan.

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

• Use of over the counter medication within 7 days of dosing and anticipated use through the follow-up visit

• Use of prescription medication within 14 days of dosing and anticipated use through the follow-up visit

• 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