Asthma Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Study of the Safety and Tolerability of Increasing Doses of XC8 After Single and Repeated Oral Administration in Healthy Volunteers
Verified date | February 2018 |
Source | PHARMENTERPRISES LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. The volunteers received the study drug once, and then continued daily
intake for 14 days after a 6-day break.
The primary objective of the study was to evaluate the safety and tolerability profile for
XC8 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 XC8.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 7, 2015 |
Est. primary completion date | July 7, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Non-smoking men aged 18 to 50 years (inclusive); 2. Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination; 3. Body mass index of 19 to 30 kg/m2 (inclusive); 4. Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide); 5. Signed patient information sheet and informed consent form for participation in the study. Exclusion Criteria: 1. 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; 2. Laboratory abnormalities at screening; 3. Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening; 4. Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test; 5. The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.); 6. Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening; 7. History of allergies (including medicines and food products); 8. Symptomatic rhinitis in anamnesis during 2 years prior to screening (allergic rhinitis, non-allergic rhinitis or pollinosis); 9. Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening; 10. Participation in other clinical trials or taking the study drug during 3 months before screening; 11. Impossibility to understand or follow protocol instructions; 12. Smoking 3 months before screening; 13. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption; 14. Acute infectious diseases less than 4 weeks before the start of the study. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | 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 |
Lead Sponsor | Collaborator |
---|---|
PHARMENTERPRISES LLC |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Adverse events per treatment arm | Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version. For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects | Change from pre-dose to Day 50 | |
Primary | Physical examination | Physical examination results will be listed for following: general appearance, skin, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest, heart, abdomen (including liver examination), extremities, and nervous system. | Day 1 till Day 36 | |
Primary | 12-lead ECG | 12-lead ECG results will be analyzed descriptively | Change from pre-dose till Day 36 | |
Secondary | Pharmacokinetics of XC8 by assessing AUC0-inf | Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity | Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose) | |
Secondary | Pharmacokinetics of XC8 by assessing Cmax | Maximum plasma concentration | Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose) | |
Secondary | Pharmacokinetics of XC8 by assessing AUC0-t | Area under the curve "concentration of the drug-time" from the time of administration of the drug till the time (t) the last blood sampling | Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose) | |
Secondary | Pharmacokinetics of XC8 by assessing Tmax | Time to maximum drug concentration in the blood plasma administration | Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose) | |
Secondary | Pharmacokinetics of XC8 by assessing T1/2 | Terminal elimination half-life | Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose) | |
Secondary | Pharmacokinetics of XC8 by assessing kel | Elimination rate constant | Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose) | |
Secondary | Pharmacokinetics of XC8 by assessing Cav | Average concentration over one dosing interval | Day 8 to 12 and 15 (Pre dose); Day 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 22 (24 hours ±10 minutes post dose |
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