Status:
COMPLETED
XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers
Lead Sponsor:
PHARMENTERPRISES LLC
Conditions:
Asthma
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of XC8 after single and repeated oral administration in healthy volunteers. Th...
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 administrat...
Eligibility Criteria
Inclusion
- Non-smoking men aged 18 to 50 years (inclusive);
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Body mass index of 19 to 30 kg/m2 (inclusive);
- Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide);
- Signed patient information sheet and informed consent form for participation in the study.
Exclusion
- Hepatic disorder or renal disease; any other disease that, in the opinion investigator, may affect the results of the study, or may lead to the health aggravation during the study;
- Laboratory abnormalities at screening;
- Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
- Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;
- The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
- Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening;
- History of allergies (including medicines and food products);
- Symptomatic rhinitis in anamnesis during 2 years prior to screening (allergic rhinitis, non-allergic rhinitis or pollinosis);
- Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
- Participation in other clinical trials or taking the study drug during 3 months before screening;
- Impossibility to understand or follow protocol instructions;
- Smoking 3 months before screening;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Acute infectious diseases less than 4 weeks before the start of the study.
Key Trial Info
Start Date :
February 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03441815
Start Date
February 14 2015
End Date
July 7 2015
Last Update
February 22 2018
Active Locations (1)
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1
SBEI HPE The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation, University Hospital #2, Department of Development of New Medicines
Moscow, Russia, 119435