Healthy VolunteersPhase 1NCT05628116
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.
A Phase 1 study testing XC243 50 mg single, XC243 100 mg single and XC243 200 mg single-dose food effect in people with Healthy Volunteers, run by PHARMENTERPRISES LLC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- XC243 50 mg single, XC243 100 mg single and XC243 200 mg single-dose food effect
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteRussia
- Study dates
- 28 Sep 2022to 21 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteer read, understood and signed the Information Leaflet and the Informed Consent Form to participate in the study;
- Non-smoking men (nonsmokers at least within the last year before the screening) at the ages from 18 through 45;
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Blood Pressure (BP): Systolic blood pressure (SBP) 100 to 130 mm Hg, diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);
- Heart rate (HR) from 60 to 90 units/min (inclusive);
- Respiratory rate (RR) from 12 to 20 min-1 (inclusive);
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- Body temperature from 36 to 36.9 ° C (inclusive);
- Body mass index from 18.5 to 30.0 kg/m2 with body weight of more than 45 kg and no more than 110 kg;
- Negative result of breath alcohol test, urine test for narcotic substances;
- Consent to use adequate contraceptive methods throughout the study, including the post-observation period (7 days in Cohorts 1-3 and 14 days in Cohort 4), as well as 90 days at its end;
- Agreement to observe the daily and nutritional regimen provided for by the study protocol.
Who cannot join
- The history of chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, musculoskeletal system, as well as the gastrointestinal tract (GI), liver, kidneys, blood, mental illness, epilepsy or seizure;
- Deviations of standard laboratory and instrumental values, as well as physical examination results from normal values at screening;
- History of GI surgery (excluding appendectomy);
- Administration of drugs less than 2 weeks before screening (including preparations of plant origin, vitamins and dietary supplements), with the exception of episodic administration of paracetamol at a dose of up to 1.5 g/day;
- Taking drugs that affect liver function (for example, inhibitors and/or inducers of cytochrome P450) less than 30 days before screening;
- Presence of antibodies to HIV and hepatitis C virus at screening, presence of hepatitis B virus surface antigen, presence of antibodies to T. Pallidum *;
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- Presence of a positive test for SARS-CoV-2 at screening;
- Presence of unstable sleep structure (for example, night shift work, sleep disturbances, insomnia, recent return from another time zone, etc.), extreme physical activity (for example, lifting weights);
- A special diet (for example, vegetarian, vegan, hypocaloric (less than 1000 kcal/day));
- Taking alcohol within 4 days of screening or testing positive for exhaled alcohol at screening or on Day -1;
- Taking narcotic drugs within 4 days before screening or a positive urine drug test at screening or on Day -1;
- History of alcohol and/or drug dependence or intake of more than 5 units of alcohol per week (one unit of alcohol is 40 ml of strong alcoholic beverages, 330 ml of beer or 150 ml of wine) since the beginning of the screening stage;
- Smoking or using nicotine-containing products at present and for 6 months prior to screening;
- History of allergic and/or hypersensitivity reactions to drugs;
- Hypersensitivity to study drug components;
- Blood/plasma donation (450 ml blood or plasma or more) less than 2 months prior to screening;
- Vaccination with live vaccines less than 90 days before screening;
- Participate in other clinical trials or take study medication within 3 months prior to screening. Volunteers who have not been screened in another study, as well as volunteers who have not been included in another study, can be included in this study;
- Acute infectious diseases less than 4 weeks prior to screening;
- Inability to read or write; unwillingness to understand and follow study protocol procedures; failure to perform procedures that the Investigator believes may affect the study results or safety of the volunteer and prevent the volunteer from entering the study;
- Any concomitant medical or serious mental conditions that render a volunteer unfit to participate in a clinical trial limit the validity of obtaining informed consent or may affect the volunteer's ability to participate in the study, in the reasonable opinion of the study physician;
- Site staff, regardless of participation in this clinical trial, members of their families or subjects in dependent relationships.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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).
Read the 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
- Being tested
- XC243 50 mg single, XC243 100 mg single, Placebo single, XC243 200 mg single-dose food effect, Placebo single-dose food effect
- Keywords
- Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC243 50 mg singleDrug
The volunteers will receive a single dose of the ID (1 tablet once, 50 mg)
XC243 100 mg singleDrug
The volunteers will receive a single dose of the ID (2 tablets once, 100 mg)
Placebo singleDrug
The volunteers will receive a single dose of the ID (1 or 2 tablets once)
XC243 200 mg single-dose food effectDrug
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)
Placebo single-dose food effectDrug
The volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets)
XC243 200 mg multipleDrug
The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily, 200 mg each)
Placebo multipleDrug
The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily)
| Study group | Role | What they receive |
|---|---|---|
| XC243 50 mg single | Experimental | Cohort 1 - 7 subjects will be randomized in a 5:2 ratio to be treated either XC243 50 mg (5 subjects) or placebo (2 subjects, see placebo single arm) Receives: Drug: XC243 50 mg single |
| XC243 100 mg single | Experimental | Cohort 2 - 7 subjects will be randomized in a 5:2 ratio to be treated either XC243 100 mg (5 subjects) or placebo (2 subjects, see placebo single arm) Receives: Drug: XC243 100 mg single |
| Placebo single | Placebo comparator | Placebo comparator arm will consist of 4 subjects (1 subject each from Сohorts 1 and 2) Receives: Drug: Placebo single |
| XC243 200 mg single-dose food effect | Experimental | Cohort 3 - 14 subjects will be randomized in a 12:2 ratio to be treated either XC243 200 mg (12 subjects) or placebo (2 subjects, see placebo single arm) first on an empty stomach, and after the washing period after eating Receives: Drug: XC243 200 mg single-dose food effect |
| Placebo single-dose food effect | Placebo comparator | Placebo comparator arm will consist of 2 subjects from Cohort 3 Receives: Drug: Placebo single-dose food effect |
| XC243 200 mg multiple | Experimental | Cohort 4 - 10 subjects will be randomized in a 8:2 ratio to be treated either XC243 200 mg (8 subjects) or placebo (2 subjects, see placebo multiple arm) Receives: Drug: XC243 200 mg multiple |
| Placebo multiple | Placebo comparator | Placebo comparator arm will consist of 2 subjects from cohort 4 Receives: Drug: Placebo multiple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events (AEs) per treatment arm
Adverse events will be classified according to CTCAE. 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.
Measured: Day 1-Day 35
Secondary outcomes (5)
Pharmacokinetics of XC243 by assessing AUC0-inf
Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity.
Measured: Day 1- Day 14
Pharmacokinetics of XC243 by assessing Cmax
Maximum plasma concentration
Measured: Day 1- Day 14
Pharmacokinetics of XC243 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
Measured: Day 1- Day 14
Pharmacokinetics of XC243 by assessing Tmax
Time to maximum drug concentration in the blood plasma administration
Measured: Day 1- Day 14
Pharmacokinetics of XC243 by assessing T1/2
Terminal elimination half-life
Measured: Day 1- Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start28 Sep 2022
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628116
- Sponsor's protocol ID
- PAIN-ХС243-01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05628116
- Acronym / sponsor ID
- PAIN-ХС243-01
- Conditions
- Healthy Volunteers
- Keywords
- Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| XC243 50 mg single | Experimental | Drug: XC243 50 mg singleCohort 1 - 7 subjects will be randomized in a 5:2 ratio to be treated either XC243 50 mg (5 subjects) or placebo (2 subjects, see placebo single arm) |
| XC243 100 mg single | Experimental | Drug: XC243 100 mg singleCohort 2 - 7 subjects will be randomized in a 5:2 ratio to be treated either XC243 100 mg (5 subjects) or placebo (2 subjects, see placebo single arm) |
| Placebo single | Placebo comparator | Drug: Placebo singlePlacebo comparator arm will consist of 4 subjects (1 subject each from Сohorts 1 and 2) |
| XC243 200 mg single-dose food effect | Experimental | Drug: XC243 200 mg single-dose food effectCohort 3 - 14 subjects will be randomized in a 12:2 ratio to be treated either XC243 200 mg (12 subjects) or placebo (2 subjects, see placebo single arm) first on an empty stomach, and after the washing period after eating |
| Placebo single-dose food effect | Placebo comparator | Drug: Placebo single-dose food effectPlacebo comparator arm will consist of 2 subjects from Cohort 3 |
| XC243 200 mg multiple | Experimental | Drug: XC243 200 mg multipleCohort 4 - 10 subjects will be randomized in a 8:2 ratio to be treated either XC243 200 mg (8 subjects) or placebo (2 subjects, see placebo multiple arm) |
| Placebo multiple | Placebo comparator | Drug: Placebo multiplePlacebo comparator arm will consist of 2 subjects from cohort 4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- The volunteer read, understood and signed the Information Leaflet and the Informed Consent Form to participate in the study;
- Non-smoking men (nonsmokers at least within the last year before the screening) at the ages from 18 through 45;
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Blood Pressure (BP): Systolic blood pressure (SBP) 100 to 130 mm Hg, diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);
- Heart rate (HR) from 60 to 90 units/min (inclusive);
Key exclusion criteria (22 listed)
- The history of chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, musculoskeletal system, as well as the gastrointestinal tract (GI), liver, kidneys, blood, mental illness, epilepsy or seizure;
- Deviations of standard laboratory and instrumental values, as well as physical examination results from normal values at screening;
- History of GI surgery (excluding appendectomy);
- Administration of drugs less than 2 weeks before screening (including preparations of plant origin, vitamins and dietary supplements), with the exception of episodic administration of paracetamol at a dose of up to 1.5 g/day;
- Taking drugs that affect liver function (for example, inhibitors and/or inducers of cytochrome P450) less than 30 days before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC243 50 mg singleThe volunteers will receive a single dose of the ID (1 tablet once, 50 mg) | Drug | XC243 50 mg single |
| XC243 100 mg singleThe volunteers will receive a single dose of the ID (2 tablets once, 100 mg) | Drug | XC243 100 mg single |
| Placebo singleThe volunteers will receive a single dose of the ID (1 or 2 tablets once) | Drug | Placebo single |
| XC243 200 mg single-dose food effectThe 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 | XC243 200 mg single-dose food effect |
| Placebo single-dose food effectThe volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets) | Drug | Placebo single-dose food effect |
| XC243 200 mg multipleThe volunteers will receive multiple doses of the ID during 14 days (4 tablets daily, 200 mg each) | Drug | XC243 200 mg multiple |
| Placebo multipleThe volunteers will receive multiple doses of the ID during 14 days (4 tablets daily) | Drug | Placebo multiple |
Primary outcome
Number of Adverse events (AEs) per treatment arm
Time frame: Day 1-Day 35
Adverse events will be classified according to CTCAE. 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.
5 secondary outcomes
Pharmacokinetics of XC243 by assessing AUC0-inf
Time frame: Day 1- Day 14
Pharmacokinetics of XC243 by assessing Cmax
Time frame: Day 1- Day 14
Pharmacokinetics of XC243 by assessing AUC0-t
Time frame: Day 1- Day 14
Pharmacokinetics of XC243 by assessing Tmax
Time frame: Day 1- Day 14
Pharmacokinetics of XC243 by assessing T1/2
Time frame: Day 1- Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XC243 50 mg single, XC243 100 mg single and XC243 200 mg single-dose food effect in people with Healthy Volunteers, run by PHARMENTERPRISES LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse events (AEs) per treatment arm (time frame: Day 1-Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.