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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.

NCT05628116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-11-18

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

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)

Sponsors & Collaborators

  • PHARMENTERPRISES LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2023-09-21
Completion
2023-09-21

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628116 on ClinicalTrials.gov