Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers
Status:
Completed
Trial end date:
2017-09-26
Target enrollment:
Participant gender:
Summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and
tolerability of increasing doses of drug XC221 after single and repeated oral administration
in healthy volunteers. The volunteers received the study drug once, and then continued daily
intake for 5 days after a 6-day break. The primary objective of the study was to evaluate the
safety and tolerability profile for drug XC221 after single and multiple administration based
on the frequency and severity of adverse events and changes in vital signs, laboratory
results, electrocardiography and results of the physical examination. The secondary objective
of the study was to assess pharmacokinetics of active pharmaceutical substance XC221GI and
its metabolite XC221A.