NCT05628116

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.

Double-blind, Randomized, Placebo-controlled, Phase I Clinical Study of the Safety, Tolerability and Pharmacokinetics of Ascending Doses of X243 After Single and Multiple Oral Administration in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: PHARMENTERPRISES LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	XC243 50 mg single	The volunteers will receive a single dose of the ID (1 tablet once, 50 mg)
DRUG	XC243 100 mg single	The volunteers will receive a single dose of the ID (2 tablets once, 100 mg)
DRUG	Placebo single	The volunteers will receive a single dose of the ID (1 or 2 tablets once)
DRUG	XC243 200 mg single-dose food effect	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)
DRUG	Placebo single-dose food effect	The volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets)
DRUG	XC243 200 mg multiple	The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily, 200 mg each)
DRUG	Placebo multiple	The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily)

Timeline

• Start date: 2022-09-28
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2022-11-28
• Last updated: 2023-11-18

Locations

1 site across 1 country: Russia