Metabolic SyndromePhase 1NCT04428593
Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers
A Phase 1 study testing Treamid 5 mg, Treamid 15 mg and Treamid 50 mg in people with Metabolic Syndrome, run by PHARMENTERPRISES LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Treamid 5 mg, Treamid 15 mg and Treamid 50 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2016to 21 Nov 2016
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 13Show fewer
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Treamid 5 mg, Treamid 15 mg, Treamid 50 mg, Placebo
- Keywords
- Healthy volunteers, PHARMENTERPRISES, Phase I
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treamid 5 mgDrug
Also called XC268BG
The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
Treamid 15 mgDrug
Also called XC268BG
The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
Treamid 50 mgDrug
Also called XC268BG
The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
PlaceboDrug
The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day -13 (14 days before first dose) - Day 50
Secondary outcomes (5)
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
Measured: 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
Maximum plasma concentration
Measured: 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
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 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
Time to maximum drug concentration in the blood plasma administration
Measured: 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
Terminal elimination half-life
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start25 Jan 2016
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena A Smolyarchuk, MD, PhD, Principal investigator, The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428593
- Sponsor's protocol ID
- METS-TRE-01
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 17 Jun 2020
- 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 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04428593
- Acronym / sponsor ID
- METS-TRE-01
- Conditions
- Metabolic Syndrome
- Keywords
- Healthy volunteers, PHARMENTERPRISES, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 11 Jun 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treamid 5 mg | Experimental | Drug: Treamid 5 mgCohort 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). |
| Treamid 15 mg | Experimental | Drug: Treamid 15 mgCohort 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). |
| Treamid 50 mg | Experimental | Drug: Treamid 50 mgCohort 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 | Placebo comparator | Drug: PlaceboPlacebo comparator arm consists of 4 subjects (1 subject from Сohorts 1 and 2, 2 subjects from Cohort 3). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.);
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 |
|---|---|---|
| Treamid 5 mgAlso: XC268BGThe volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. | Drug | Treamid 5 mg |
| Treamid 15 mgAlso: XC268BGThe volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. | Drug | Treamid 15 mg |
| Treamid 50 mgAlso: XC268BGThe volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. | Drug | Treamid 50 mg |
| PlaceboThe volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. | Drug | Placebo |
Primary outcome
Number of Adverse events per treatment arm Number of Adverse events per treatment arm
Time frame: Day -13 (14 days before first dose) - Day 50
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.
5 secondary outcomes
Pharmacokinetics of Treamid by assessing AUC0-inf
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)
Pharmacokinetics of Treamid by assessing Cmax
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)
Pharmacokinetics of Treamid by assessing AUC0-t
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)
Pharmacokinetics of Treamid by assessing Tmax
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)
Pharmacokinetics of Treamid by assessing T1/2
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)
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 17 Jun 2020.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Elena A Smolyarchuk, MD, PhD principal investigator
The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treamid 5 mg, Treamid 15 mg and Treamid 50 mg in people with Metabolic Syndrome, run by PHARMENTERPRISES LLC.
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 5 inclusion and 13 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 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 per treatment arm Number of Adverse events per treatment arm (time frame: Day -13 (14 days before first dose) - Day 50). 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 17 Jun 2020.