NCT03459391

Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers

A Double-blind, Randomized, Placebo-controlled Study of the Safety,Tolerability and Pharmacokinetics of Increasing Doses of XC221 After Single and Repeated Oral Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: PHARMENTERPRISES LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

One Russian center was approved for participation in this study. One center was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administration, multiple administration and follow-up. All eligible subjects were randomized into the study in appropriate cohort groups sequentially. Cohort 1 - XC221 or Placebo 60 mg once and then daily 5 days after a 6-day break; Cohort 2 - XC221 or Placebo 200 mg once and then daily during 5 days after a 6-day break. The decision regarding increasing of the study drug dose for a subsequent cohort was made by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment. A total of 24 volunteers received XC221 (60 mg or 200 mg) and a total of 8 volunteers received the placebo during the study participation. The follow-up period lasted for 4 weeks.

Conditions

• Influenza
• Acute Respiratory Infection

Interventions

Type	Name	Description
DRUG	XC221 60 mg	The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
DRUG	XC221 200 mg	The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
DRUG	Placebo	The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.

Timeline

• Start date: 2017-05-22
• Primary completion: 2017-09-26
• Completion: 2017-09-26
• First posted: 2018-03-08
• Last updated: 2018-03-08

Locations

1 site across 1 country: Russia