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

NCT04428593 | Completed Phase 1 DMC

• 1 other identifier: METS-TRE-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

Healthy volunteers; PHARMENTERPRISES; Phase I

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• Pharmacokinetics of Treamid by assessing AUC0-inf

  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)

• Pharmacokinetics of Treamid by assessing Cmax

  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)

• Pharmacokinetics of Treamid by assessing AUC0-t

  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)

• Pharmacokinetics of Treamid by assessing Tmax

  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)

• Pharmacokinetics of Treamid by assessing T1/2

  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)

Study Arms (4)

Treamid 5 mg

EXPERIMENTAL

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).

Drug: Treamid 5 mg

Treamid 15 mg

EXPERIMENTAL

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).

Drug: Treamid 15 mg

Treamid 50 mg

EXPERIMENTAL

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).

Drug: Treamid 50 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Treamid 5 mg DRUG

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

Also known as: XC268BG

Treamid 5 mg

Treamid 15 mg DRUG

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

Also known as: XC268BG

Treamid 15 mg

Treamid 50 mg DRUG

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

Also known as: XC268BG

Treamid 50 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

N,N'-bis(2-(1H-imidazol-2-yl)ethyl)pentanediamide

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elena A Smolyarchuk, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding was carried out by using Placebo equivalent to Treamid tablets without active substance and the corresponding labeling of the study drug.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: January 25, 2016
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: June 17, 2020

Record last verified: 2020-06