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

NCT03459391 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-03-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • PHARMENTERPRISES LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2017-09-26
Completion
2017-09-26

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459391 on ClinicalTrials.gov