Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Doses of XC243 After Single and Multiple Oral Administration in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety,
      tolerability and pharmacokinetics (PK) of ascending doses of XC243 after single and multiple
      oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of
      7 volunteers who will receive a single dose of XC243 (50 mg and 100 mg) or placebo (cohort
      ratio 5:2), 1 cohort of 14 volunteers who will receive a single dose of XC243 200 mg or
      placebo first on an empty stomach, and after the washing period after eating (cohort ratio
      12:2) and 1 cohort of 10 volunteers who will receive XC243 200 mg or placebo on an empty
      stomach during 14 days (cohort ratio 8:2).
    

Detailed description: 
      The study will be conducted in 1 centre. The study will consist of 3 parts: single-dose
      ascending study, single-dose food effect study for dose 200 mg, repeated dose study of 200 mg
      over 14 days.

      The volunteers of single dosing cohorts will receive the investigated drug (ID) ХС243 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 XC243 50 mg cohort, the Data Safety Monitoring Committee (DSMC) will
      consider dose increase and entry of the 100 mg cohort. If the single dose of ХС243 100 mg is
      considered to be safe, the third dosing cohort of 200 mg will be included in the single-dose
      food effect study.

      The volunteers of third dosing cohort will receive the ID ХС243 (200 mg) or placebo once on
      an empty stomach.The Follow-up will last 7 days, during which safety parameters and PK in
      volunteers will be studied. The washing period will last 7 days, after which volunteers will
      receive the ID ХС243 (200 mg) or placebo once after eating. The Follow-up will last 7 days
      too. If the single dose of ХС243 200 mg is considered to be safe, the fourth multiple dosing
      cohort of repeated dose of 200 mg will be included.

      The volunteers from multiple dosing cohort will receive the ID (ХС243 or placebo) once a day
      during 14 days and will stay at the hospital (study center) within 15 days. The Follow-up
      will last 14 days, during which they will study safety parameters and PK in volunteers.
    

Intervention name(s): XC243 50 mg single; XC243 100 mg single; Placebo single; XC243 200 mg single-dose food effect; Placebo single-dose food effect; XC243 200 mg multiple; Placebo multiple
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): The volunteers will receive a single dose of the ID (1 tablet once, 50 mg); The volunteers will receive a single dose of the ID (2 tablets once, 100 mg); The volunteers will receive a single dose of the ID (1 or 2 tablets once); The volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets, 200 mg); The volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets); The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily, 200 mg each); The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The dose cohorts will be included into the study subsequently based on preliminary safety results evaluation performed by the DSMC. 2 doses of XC243/placebo (50 mg, 100 mg) were used in the single-dose ascending study. 1 dose of XC243/placebo (200 mg) were used in the single-dose food effect study. 1 dose of XC243/placebo (200 mg) were used in the repeated dose study.The duration of exposure to the ID is planned 1 day in single dosing cohorts and 14 days in multiple dosing cohort.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 1