drugset / Trial / NCT02448264

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

NCT02448264

Phase 1 Completed 122 enrolled BioCryst Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-05
Primary completion
2015-11
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject berotralstat Small molecule Oral

Indications