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Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Treamid 5 mg

Treamid 15 mg

Treamid 50 mg

Placebo

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Healthy volunteers, PHARMENTERPRISES, Phase I

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Non-smoking male at the age from 18 to 50 years old (inclusive);
Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
Body mass index from 18.5 to 30 kg/m2 (inclusive);
Agreement to use adequate contraception methods during the study and 3 months after its completion (condoms with spermicide);
Signed patient explanation sheet and informed consent for participation in the study.

Exclusion Criteria:

Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems and diseases of the gastrointestinal tract, liver, kidneys, blood;
Laboratory deviations from normal values at screening (the deviations will not include single violations of reference ranges of laboratory parameter if they are not accompanied with any clinical symptoms, do not require additional examination or treatment and are not confirmed by values of related laboratory parameters);
Regular administration of drugs in less than 2 weeks before starting the study; administration of drugs effecting on hemodynamics, liver function, and others. (barbiturates, omeprazole, cimetidine, etc.) in less than 30 days before starting the study;
Antibodies to HIV and hepatitis C, hepatitis B surface antigen, positive test for syphilis;
Unstable sleep architecture (e.g. night work, sleep disorders, insomnia, recently returned from another time zone, etc.);
Signs of alcohol or drug addiction; taking alcohol or narcotic drugs during 4 days prior to screening (taking more than 10 units of alcohol per week (1 unit of alcohol is equivalent ½ liters of beer, 200 ml of wine or 50 ml of hard alcoholic beverages);
Medical history significant for allergic (including drug intolerance and food allergies);
Symptomatic rhinitis in past medical history during 2 years before screening (allergic rhinitis, non-allergic rhinitis or allergic coryza);
Blood/plasma donation (from 450 ml) in less than 2 months prior to screening;
Surgeries in hospital environment (except appendectomy) during 12 weeks prior to screening;
Participation in other clinical studies or taking other investigated drugs during 3 months prior to screening;
Inability to understand or comply with the protocol procedures;
Acute infectious diseases in less than 4 weeks prior to screening.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Treamid 5 mg

Treamid 15 mg

Treamid 50 mg

Placebo

Arm Description

Cohort 1 - 5 subjects were randomized in a 4:1 ratio to be treated either Treamid 5 mg (4 subjects) or placebo (1 subject, see placebo arm).

Cohort 2 - 5 subjects were randomized in a 4:1 ratio to be treated either Treamid 15 mg (4 subjects) or placebo (1 subject, see placebo arm).

Cohort 3 - 5 subjects were randomized in a 8:2 ratio to be treated either Treamid 50 mg (8 subjects) or placebo (2 subjects, see placebo arm).

Placebo comparator arm consists of 4 subjects (1 subject from Сohorts 1 and 2, 2 subjects from Cohort 3).

Outcomes

Primary Outcome Measures

Number of Adverse events per treatment arm Number of Adverse events per treatment arm

Adverse events have been 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. For each preferred term, frequency counts and percentages will be calculated by cohort. The nature, severity, seriousness, and relationship to study drug will be summarized for all study subjects.

Secondary Outcome Measures

Pharmacokinetics of Treamid by assessing AUC0-inf

Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity

Pharmacokinetics of Treamid by assessing Cmax

Maximum plasma concentration

Pharmacokinetics of Treamid 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

Pharmacokinetics of Treamid by assessing Tmax

Time to maximum drug concentration in the blood plasma administration

Pharmacokinetics of Treamid by assessing T1/2

Terminal elimination half-life

Full Information

NCT ID

NCT04428593

First Posted

June 10, 2020

Last Updated

June 15, 2020

Sponsor

PHARMENTERPRISES LLC

1. Study Identification

Unique Protocol Identification Number

NCT04428593

Brief Title

Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers

Official Title

Double Blind, Randomized, Placebo-controlled Study of Safety and Tolerability of Treamid in Rising Doses at Single and Then Multiple Oral Administration in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

January 25, 2016 (Actual)

Primary Completion Date

November 21, 2016 (Actual)

Study Completion Date

November 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PHARMENTERPRISES LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of Treamid after single and repeated oral administration in healthy volunteers. The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. The primary objective of the study was to evaluate the safety and tolerability profile of Treamid after single and multiple administration based on the frequency and severity of adverse events and changes in vital signs, laboratory results, electrocardiography and results of the physical examination. The secondary objective of the study was to assess pharmacokinetics of active pharmaceutical substance of Treamid.

Detailed Description

1 Russian center was approved for participation in this study and was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administration, multiple administration and follow-up. All eligible subjects were randomized into the study in appropriate cohort groups sequentially. Cohort 1 - Treamid or Placebo 5 mg once and then daily 14 days after a 6-day break; Cohort 2 - Treamid or Placebo 15 mg once and then daily during 14 days after a 6-day break; Cohort 3 - Treamid or Placebo 50 mg once and then daily during 14 days after a 6-day break. The decision regarding increasing of the study drug dose for a subsequent cohort was made by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment. A total of 16 volunteers received Treamid (4 - 5 mg, 4 -15 mg, 8 - 50 mg) and a total of 4 volunteers received the placebo during the study participation. The follow-up period lasted for 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Healthy volunteers, PHARMENTERPRISES, Phase I

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

The dose cohorts were included into the study subsequently based on preliminary safety results evaluation performed by the Data Safety Monitoring Committee. 3 doses of Treamid/placebo (5 mg, 15 mg and 50 mg) were used in the study.The duration of exposure to the study drug was 6 days in each cohort: Day 1, once, at the step of single administration, and then in 6 days, daily, 1 time a day for 14 days at the step of multiple administration.

Masking

ParticipantInvestigator

Masking Description

Blinding was carried out by using Placebo equivalent to Treamid tablets without active substance and the corresponding labeling of the study drug.

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treamid 5 mg

Arm Type

Experimental

Arm Description

Cohort 1 - 5 subjects were randomized in a 4:1 ratio to be treated either Treamid 5 mg (4 subjects) or placebo (1 subject, see placebo arm).

Arm Title

Treamid 15 mg

Arm Type

Experimental

Arm Description

Cohort 2 - 5 subjects were randomized in a 4:1 ratio to be treated either Treamid 15 mg (4 subjects) or placebo (1 subject, see placebo arm).

Arm Title

Treamid 50 mg

Arm Type

Experimental

Arm Description

Cohort 3 - 5 subjects were randomized in a 8:2 ratio to be treated either Treamid 50 mg (8 subjects) or placebo (2 subjects, see placebo arm).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparator arm consists of 4 subjects (1 subject from Сohorts 1 and 2, 2 subjects from Cohort 3).

Intervention Type

Drug

Intervention Name(s)

Treamid 5 mg

Other Intervention Name(s)

XC268BG

Intervention Description

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

Intervention Type

Drug

Intervention Name(s)

Treamid 15 mg

Other Intervention Name(s)

XC268BG

Intervention Description

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

Intervention Type

Drug

Intervention Name(s)

Treamid 50 mg

Other Intervention Name(s)

XC268BG

Intervention Description

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

Primary Outcome Measure Information:

Title

Number of Adverse events per treatment arm Number of Adverse events per treatment arm

Description

Time Frame

Day -13 (14 days before first dose) - Day 50

Secondary Outcome Measure Information:

Title

Pharmacokinetics of Treamid by assessing AUC0-inf

Description

Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity

Time Frame

Day 1 and Day 21 (Pre dose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 6, 8 and 12 hours post dose), Day 2 and Day 22 (24 hours post dose), Day 3 (48 hours post dose), Day 4 (72 hours post dose), Days 8 - 12 and Day 15 (Pre dose)

Title

Pharmacokinetics of Treamid by assessing Cmax

Description

Maximum plasma concentration

Time Frame

Title

Pharmacokinetics of Treamid by assessing AUC0-t

Description

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

Title

Pharmacokinetics of Treamid by assessing Tmax

Description

Time to maximum drug concentration in the blood plasma administration

Time Frame

Title

Pharmacokinetics of Treamid by assessing T1/2

Description

Terminal elimination half-life

Time Frame

Day 1 and Day 21 (Pre dose, 15 minites, 30 minutes, 1, 1.5, 2, 3, 6, 8 and 12 hours post dose), Day 2 and Day 22 (24 hours post dose), Day 3 (48 hours post dose), Day 4 (72 hours post dose), Days 8 - 12 and Day 15 (Pre dose)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-smoking male at the age from 18 to 50 years old (inclusive); Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination; Body mass index from 18.5 to 30 kg/m2 (inclusive); Agreement to use adequate contraception methods during the study and 3 months after its completion (condoms with spermicide); Signed patient explanation sheet and informed consent for participation in the study. Exclusion Criteria: Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems and diseases of the gastrointestinal tract, liver, kidneys, blood; Laboratory deviations from normal values at screening (the deviations will not include single violations of reference ranges of laboratory parameter if they are not accompanied with any clinical symptoms, do not require additional examination or treatment and are not confirmed by values of related laboratory parameters); Regular administration of drugs in less than 2 weeks before starting the study; administration of drugs effecting on hemodynamics, liver function, and others. (barbiturates, omeprazole, cimetidine, etc.) in less than 30 days before starting the study; Antibodies to HIV and hepatitis C, hepatitis B surface antigen, positive test for syphilis; Unstable sleep architecture (e.g. night work, sleep disorders, insomnia, recently returned from another time zone, etc.); Signs of alcohol or drug addiction; taking alcohol or narcotic drugs during 4 days prior to screening (taking more than 10 units of alcohol per week (1 unit of alcohol is equivalent ½ liters of beer, 200 ml of wine or 50 ml of hard alcoholic beverages); Medical history significant for allergic (including drug intolerance and food allergies); Symptomatic rhinitis in past medical history during 2 years before screening (allergic rhinitis, non-allergic rhinitis or allergic coryza); Blood/plasma donation (from 450 ml) in less than 2 months prior to screening; Surgeries in hospital environment (except appendectomy) during 12 weeks prior to screening; Participation in other clinical studies or taking other investigated drugs during 3 months prior to screening; Inability to understand or comply with the protocol procedures; Acute infectious diseases in less than 4 weeks prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena A Smolyarchuk, MD, PhD

Organizational Affiliation

The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers

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