A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 4 volunteers who will receive a single dose of XC7 (100 mg and 200 mg) or placebo (cohort ratio 3:1) and 1 cohort of 8 volunteers who will receive multiple doses of the XC7 (200 mg) or placebo during 14 days (cohort ratio 6:2).
The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7 days), treatment (1 or 14 days) and follow-up (7 or 28 days). The volunteers of single dosing cohorts will receive the investigated drug (ID) ХС7 or placebo once and stay at the study center for at least 24 hours after the ID administration to monitor the safety parameters and for sampling for PK analysis. The Follow-up will last 7 days, during which safety parameters and PK in volunteers will be studied. Based on all safety data from the XC7 100 mg cohort, the Data Safety Monitoring Committee (DSMC) will consider dose increase and entry of the 200 mg cohort. If the single dose of ХС7 200 mg is considered to be safe, the third multiple dosing cohort of 200 mg will be included in the study. The volunteers from multiple dosing cohort will receive the ID (ХС7 or placebo) once a day during 14 days and will stay at the hospital (study center) during the first five days after administration of the ID. The Follow-up will last 14 days, during which they will study safety parameters and PK in volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
The volunteers will receive a single dose of the ID (1 capsule once, 100 mg)
The volunteers will receive a single dose of the ID (2 capsules once, 100 mg each)
The volunteers will receive a single dose of the ID (1 or 2 capsules once)
The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each)
The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily)
Federal State Autonomous Educational Institution of Higher Education "The First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation
Moscow, Russia
Number of Adverse events (AEs) per treatment arm
Adverse events will be classified according to CTCAE ver 4.03. 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.
Time frame: Day -7 (7 days before first dose) - Day 58
Pharmacokinetics of XC7 by assessing AUC0-inf
Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity.
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing Cmax
Maximum plasma concentration
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 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
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing Tmax
Time to maximum drug concentration in the blood plasma administration
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing T1/2
Terminal elimination half-life
Time frame: Day 1 - Day 4
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