AzTrials
AzTrials

Infections, RespiratoryPhase 1PANCT04174937

PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

A Phase 1 study testing Potentiator of antibiotics (PA) in people with Infections, Respiratory, run by Scientific Center for Anti-infectious Drugs, Kazakhstan at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a first-in-human (FIH) study to explore the safety, tolerability and pharmacokinetics of PA after oral ascending dose administration to healthy male volunteers. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Infections, Respiratory
What is being tested?
Potentiator of antibiotics (PA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteKazakhstan
Study dates
17 Jun 2016to 15 Sep 2019
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 to 55 years
  • Body mass index 16 to 30
  • Subjects should be in good physical and mental health based on medical history, clinical examination and laboratory investigations
  • Subjects should have signed informed consent prior to screening and the clinical study after they have read and understood the objective, conduct, risks related to the study, and their rights as study participants
  • Subjects should have signed informed consent for being tested for HIV
  • Subjects should have signed informed consent to be tested for alcoholemia, use of cannabinoids, cocaine, morphine, benzodiazepines, barbiturates and amphetamine

Who cannot join

  • Subjects should not have evidence of any physical and/or mental health issues at screening and/or results of any clinical, laboratory and/or technical procedures at screening outside of the normal range
  • Subjects should not be taking any concomitant medication
  • Subjects should not have a history of allergies, hypersensitivity or intolerance to iodine or iodide or to medicines containing iodine such as contrast media used for radiologic examinations
  • Subjects should not have a history of addiction or abuse of drugs or alcohol
  • Subjects should not be in a position of subordination or other dependence on persons involved in the study such as sponsor, investigators, or any other person or institution interested in its results
  • Subjects should not be members of the armed forces or prison inmates
  • Subjects should not have positive serology for Hepatitis B, Hepatitis C or HIV
  • Subjects should not have any apparent functional and/or physical defects which may or interfere with the study or distort results

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

  • Institute Of Cardiology & Internal Diseases

    Almaty, Almatinskaya, A05B0H6

Other trials in Kazakhstan

About this study

Official title: A Randomized, Placebo-controlled Study of the Tolerability, Safety and Pharmacokinetics of PA in Healthy Volunteers

This is a first-in-human (FIH) study to explore the safety, tolerability and pharmacokinetics of PA after oral ascending dose administration to healthy male volunteers.

Read the detailed description

The first-in-human dose (FHD) trial is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of PA in healthy male subjects.

The study consists of two stages: single dose administration and multiple dose administration.

The single dose administration stage includes 5 cohorts, multiple dose administration stage includes at least 4 cohorts (groups). Each cohort includes 8 subjects (6 active drugs and 2 placebos). Cohorts intake ascending doses of study drug. The dose of 1st cohort is 1,0 mg/ml, the doses for the following cohorts will be estimated by the Data Monitoring Committee based on pharmacokinetics and safety results of previous group.

For each subject study includes screening period, one baseline period on Day -1, a treatment period (1 day - at single dose stage; 14 days - at multiple dose stage), followed by safety, PK, assessments up to 72-96 hours post dose. Follow-up visits will take place on Day 7 ; 30; 60 (single dose stage) and 30; 60; 90 (multiple dose stage).

Being tested
Potentiator of antibiotics (PA), Placebo PA
Keywords
Safety, Iodine complex, Pharmacokinetics, Antibiotic potentiator
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Potentiator of antibiotics (PA)Drug

    Also called Albumin complex of tetraiodide

    Intervention is administered to patients in this Arm

  • Placebo PAOther

    Intervention is administered to patients in this Arm

Study groups in NCT04174937
Study groupRoleWhat they receive
Potentiator of antibiotics (PA)ExperimentalPotenciator of antibiotics (PA) , albumin complex of tetraiodid was given per os, single and multiple doses for the different periods (but not exceeding 14 days)
Receives: Drug: Potentiator of antibiotics (PA)
Patients taking placebo PAPlacebo comparatorPlacebo without any active pharmaceutical ingredients was given per os dosed for the patients in same periods of time as per experimental group, single and multiple doses for the different periods (but not exceeding 14 days)
Receives: Other: Placebo PA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AE)

    The safety of ascending single and multiple doses of Study Drug in healthy male subjects will be assessed by adverse event and serious adverse event monitoring.

    Measured: Adverse event reporting will be performed throughout the trial from the Screening visit until the Final visit (up to 90 days)

Secondary outcomes (75)

  1. Area under plasma concentration time curve (AUC∞)

    AUC∞ characterizes the total concentration of a drug in serum during the entire observation time. AUC0-∞ is area under the сurve concentration of a drug in blood versus time during the entire observation time. It is calculated on the basis of experimental data. It is measured in μg*hours/liter.

    Measured: Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  2. Maximum concentration of drug in the blood (Cmax)

    Maximum concentration of drug in the blood after its intake. It is measured in μg /liter.

    Measured: Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  3. Time to reach maximum drug concentration (Tmax)

    The time required to reach maximum concentration of the drug in blood. Determined by measurements. It is measured in hours.

    Measured: Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  4. Half-life time (T1/2)

    The interval of time required to eliminate the half of drug dose from blood. It is calculated on the basis of experimental data. It is measured in hours.

    Measured: Blood collections at the following time points: 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  5. Total clearance (СL)

    The total clearance is the volume of plasma from which a substance is completely removed per the unit of time. It is calculated on the basis of experimental data. Clearance is measured in liters / hour * kg of body weight.

    Measured: Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  6. Mean residence time of drug (MRT)

    MRT is the average time of the drug molecules stays in the body. It is calculated on the basis of experimental data. It is measured in hours.

    Measured: Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  7. Drug excretion (%)

    Drug excretion with urine over specified periods of time. It is calculated on the basis of experimental data. It is defined as a percentage (%) of single dose or of the total drug amount during its multiple use.It is measured in percents (%).

    Measured: Urine samples taken during 0-96 h after drug intake

  8. Volume of distribution (Vλz)

    Volume of distribution is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma. Volume of distribution of the drug in blood is calculated base on terminal phase of drug pharmacokinetic curve. Volume of distribution is an apparent volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma. It is evaluated on the basis of experimental data. It is measured in liters / kg.

    Measured: Blood collections at the following time points: 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

  9. Drug elimination rate constant (Lambda-z (λz))

    Drug elimination rate constant in the terminal phase of the pharmacokinetic curve. Elimination rate constant characterizes absorption and excretion. It is measured in 1/hours.

    Measured: 0-72 hours

  10. Accumulation index (Rac)

    The degree of accumulation of the drug in the blood at multiple-dose administration. It is evaluated on basis experimental data.

    Measured: Blood sampling at multiple dosing: Day 1-17

  11. Change in thyroid stimulating hormone (TSH)

    TSH stimulates the thyroid gland to synthesize and secrete thyroid hormone. TSH serum measurements are used to detect primary hypo- and hyperthyroidism. The capability of a TSH assay to distinguish between normal and subnormal concentrations is essential for thyroid testing strategy. It is measured in milli international units per liter (mlU/L). Normal range for the study: 0.5-4.8 mlU/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  12. Change in total triiodothyronine (TT3)

    Total triiodothyronine measured in serum and used to diagnose thyroid diseases such as hyperthyroidism and T3-thyrotoxicosis. It is measured in nmol/L. Normal range for the study: 0.85-2.62 nmol/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  13. Change in free triiodothyronine (FT3)

    The FT3 is not bound to transport proteins in the circulating blood (unbound T3). It is metabolically active. T3 plays an important role in regulating metabolism. The Free T3 test helps determine whether the thyroid is functioning properly. It is to help diagnose hyperthyroidism and monitor the progress of a patient with a thyroid disorder. It is measured in pmol/L. Normal range for the study: 3.5-6.5 pmol/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  14. Change in total thyroxine (TT4)

    Total thyroxine is a hormone used to help diagnose hyper- and hypothyroidism. The TT4 test is usually used with a TSH test to help determine whether the thyroid hormone feedback system is functioning properly, and the results help to distinguish between causes of hyper- and hypothyroidism. It is measured in nmol/L. Normal range for the study: 54 -167 nmol/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  15. Change in free thyroxine (FT4)

    The FT4 is an unbound fraction of thyroxine. It is not bound to transport proteins, free in the circulation. The free T4 is metabolically active. It is used in combination with TSH for the diagnosis of thyroid disorders and follow-up of patients with thyroid disorders. It is measured in pmol/L. Normal range for the study: 10-22 pmol/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  16. Change in anti-thyroglobulin antibody

    Thyroglobulin (Tg) is a glycoprotein found in thyroid follicular cells that plays a critical role in the biosynthesis of key thyroid hormones. The measurement of anti-TG antibody has been shown to be an aid in the diagnosis of thyroid disorders. It is measured in kilo international units per liter (klU/L). Normal range for the study: up to 40 klU/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  17. Change in anti-thyroid peroxidase antibody

    Anti-thyroid peroxidase antibody is a protein found in thyroid follicular cells, is a catalyst in the synthesis of key thyroid hormones. Elevated levels of anti-TPO antibody are a risk factor for autoimmune thyroid diseases. It is measured in klU/L. Normal range for the study: up to 35 klU/L.

    Measured: Screening visit; Single dose intake: Day 1 - before and 12 hours after dose; Day 2; Day 3; Day 60. Multiple dose intake: Day 1 - before and 12 hours after dosing; Days 2;3;5;9;14;17;30;60;90

  18. Change from baseline in thyroid ultrasound

    Thyroid Ultrasound is used to assess the size of the Thyroid gland and to find out if there are nodules or lesions within the gland. Also the test is used to suspect thyroid disease at screening visit to not include volunteer into the trial.

    Measured: Screening visit; Final visit (Day 60 - at Single dose intake; Day 90 - at Multiple dose intake)

  19. Change from baseline in electrocardiogram (ECG)

    A 12-lead resting ECG with a 10 second rhythm strip to be recorded, which includes PR, QT, and QTc intervals as well as QRS interval duration. ECG will be interpreted as "normal", "abnormal, not clinically significant", or "abnormal, clinically significant". Findings classified as "abnormal, clinically significant" will be registered as adverse events if evaluated after dosing.

    Measured: Screening visit; before dose (Day -1); Day 1 - after dose (4 hours); Final visit (Day 60). Multiple dose intake: before dose (Day -1); Day 1 and 15 - 4 hours after dose; Final visit (Day 90).

  20. Change in Respiratory Rate

    Respiratory rate is an essential vital sign and a fundamental element of patient assessment. It is assessed in combination with heart rate, blood pressure, body temperature. It is measured by counting the breaths (number of times the chest moves up and down) for a full minute in relaxed condition. Normal range for the study is 12-20 breaths per minute.

    Measured: every visit up to 90 days

  21. Change in Heart Rate

    The heart rate is one of the vital signs. It measures the number of times the heart beats per minute. It is measured in relaxed condition by checking the pulse. To calculate the beats per minute, the patient's pulse is counted for 15 seconds and multiplied by four. Normal range for the study is 60-90 beats per minute.

    Measured: every visit up to 90 days

  22. Change in Blood Pressure

    Blood Pressure is measured with a sphygmomanometer in a resting condition in three hours after study drug intake, before blood sampling. Subjects should abstain from eating, drinking, smoking one hour before measurement. The bladder should have been emptied. Subject should have been sitting quietly for about 5 minutes before the measurement. Tight clothes should have been removed. Measurements should be taken in sitting position so that the arm and back are supported. Blood Pressure is measured in millimeters of mercury (mm Hg). The systolic and diastolic blood pressure is recorded.

    Measured: every visit up to 90 days

  23. Change in Body Temperature

    Body Temperature is measured with a mercury thermometer in the armpit in a resting condition three hours after study drug intake, before blood sampling.

    Measured: every visit up to 90 days

  24. Symptoms of musculoskeletal system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any musculoskeletal symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  25. Symptoms of cardiovascular system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any cardiovascular symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  26. Symptoms of lymphatic system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any lymphatic symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  27. Symptoms of nervous system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any nervous symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  28. Symptoms of Respiratory system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any Respiratory symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  29. Symptoms of Gastrointestinal system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any gastrointestinal symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  30. Symptoms of urinary system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any urinary symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  31. Symptoms of Endocrine system

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any endocrine system symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  32. Symptoms of Skin and subcutaneous tissue

    The symptoms are recorded as a score on a scale. If there are no symptoms the result is reported as "Normal" (score=0). If there are any skin and subcutaneous tissue symptoms the result is reported as "Abnormal". Each symptom will be estimated as "Clinically non-significant" (score=1) or "Clinically significant"(score=2) and described. The relationship of symptoms with the study drug is assessed as:"Definitely related"(score=3); "Probably related"(score=2); "Possibly related"(score=1); "Not related"(score=0). The scores of clinical significance are summarized with the score of the drug relation. The higher scores mean a worse outcome.

    Measured: From baseline till the last visit (daily during hospital stay, every visit in follow-up period - up to 90 days)

  33. Change in Alanine transaminase (ALT)

    The ALT test measures the amount of ALT in the blood. High levels of ALT in the blood can indicate a liver problem, even before clinical signs of liver disease. It is measured in IU/L. Normal range for the study: ≤ 45 IU/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  34. Change in Aspartate aminotransferase (AST)

    The AST blood test measures the amount of AST in the blood. AST is an enzyme that is found mostly in the liver. AST releases into bloodstream when liver is damaged. The test can help to diagnose liver damage or disease. It is measured in IU/L. Normal range for the study: ≤ 41 IU/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  35. Change in Bilirubin / bilirubin fractions

    The level of bilirubin is measured in the blood by the bilirubin blood test. Direct bilirubin is water-soluble form of bilirubin. Indirect bilirubin is fat-soluble form of bilirubin.

    Direct and indirect are measured solely. Total and direct bilirubin levels can be measured from the blood, but indirect bilirubin is calculated from the total and direct bilirubin. It is measured in μmol/L. Normal range for the study: 8,6-20,5 μmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  36. Change in Creatinine

    Serum creatinine is measured in the blood. Creatinine measurements are used in the trial as the indicator of kidney function. Elevated creatinine level signifies impaired kidney function or kidney disease. As the kidneys become impaired for any reason, the creatinine level in the blood will rise due to poor clearance of creatinine by the kidneys. Abnormally high levels of creatinine thus warn of possible malfunction or failure of the kidneys. It is measured in μmol/L. Normal range for the study: ≤133 μmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  37. Change in Alkaline phosphatase

    The alkaline phosphatase is measured in the blood. High levels of alkaline phosphatase may indicate the liver damage. It is measured in IU/L. Normal range for the study: 40-129 IU/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  38. Change in Blood Urea Nitrogen

    The amount of urea nitrogen is measured in the blood. The urea is produced by liver in the urea cycle as a waste product of the digestion of proteins. The elevated levels of Blood Urea Nitrogen may be a sign that that kidneys aren't working efficiently. The accumulation of urea and other nitrogen-containing compounds in the blood due to renal failure leads to uremia. The main causes of an increase in Blood Urea Nitrogen are: high protein diet, decrease in glomerular filtration rate (suggestive of renal failure), decrease in blood volume (hypovolemia), congestive heart failure, gastrointestinal hemorrhage,[4] fever, and increased catabolism. Hypothyroidism can cause both decreased glomerular filtration rate and hypovolemia, but Blood Urea Nitrogen -to-creatinine ratio has been found to be lowered in hypothyroidism and raised in hyperthyroidism. It is measured in mmol/L. Normal range for the study: ≤8.3 mmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  39. Change in Uric acid

    Uric acid is a product of the metabolic breakdown of purine nucleotides, and it is a normal component of urine. High blood concentrations of uric acid may be caused by study drug, hypothyroidism, kidney damage and called hyperuricemia. It can lead to gout and are associated with other medical conditions, including diabetes and the formation of ammonium acid urate kidney stones.

    Uric acid in blood is measured in mmol/L. Normal range for the study: ≤480 mmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  40. Change in Alpha-amylase (α-amylase)

    α-amylase is an enzyme that catalyze the hydrolysis of starch into smaller carbohydrate molecules.

    The alpha-amylase is produced by the salivary glands, whereas pancreatic amylase is secreted by the pancreas into the small intestine. Both the salivary and pancreatic amylases are α-amylases.

    Blood serum amylase may be increased in case of the pancreas damage by the study drug. α-amylase in blood is measured in mmol/L. Normal range for the study: 28-100 U/L

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  41. Change in Serum total protein

    Protein in the serum consists of albumin and globulin. Protein fractions are determined using electrophoresis. Total protein levels in the blood give a general indication of the state of hydration, nutrition or proper functioning of certain major organs such as the liver, kidneys or bone marrow. Total protein in blood is measured in g/L. Normal range for the study: 64-83 g/L. Concentrations below the reference range may be a sign of low albumin concentration, liver damage, acute inflammation, or a problem of malnutrition or malabsorption of amino acids necessary for protein formation. It may be also a sign of immunodeficiency. Too much protein loss from the kidneys or too much water in the blood can also cause hypoproteinemia. Concentrations above the reference range (hyperproteinemia) may indicate dehydration or an increase in the gammaglobulin fraction, as found in chronic inflammatory diseases, certain viral infections or bone marrow disorders.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  42. Change in Albumin level in blood

    Albumin is a protein made by the liver. Albumin is measured in the blood. Albumin carries substances such as hormones, medicines, and enzymes throughout the body. Low albumin levels can indicate a problem with the liver or kidneys. Albumin in blood is measured in g/L. Normal range for the study: 35-55 g/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  43. Change in Glucose level in blood

    Measuring blood glucose levels is primarily used to monitor blood sugar levels to diagnose hyperglycemia or hypoglycemia caused by study drug. It is measured in fasting condition. Glucose in blood is measured in mmol/L. Normal range for the study: 4,11-5,89 mmol/L.

    Measured: Single dose study:Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose study: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  44. Change in Total cholesterol

    It is measured in the blood. It includes all the cholesterol in all the lipoprotein particles: high-density lipoprotein cholesterol (HDL) and low-density lipoprotein cholesterol (LDL).

    Total cholesterol in blood is measured in mmol/L. Normal range for the study: ≤5.2 mmol/L. It is used to diagnose the metabolism of lipids and the liver function.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  45. Change in Potassium in blood

    Measurement of the amount of potassium in the blood helps to diagnose an electrolyte imbalance caused by study drug. Changed potassium level (hypokaliemia, hyperkaliemia) may cause such problems as muscle weakness or contractions, nerve signals transmission, cardiac arrhythmia, hypertension, may affect the kidney function and hormone release. Potassium in the blood is measured in mmol/L. Normal range for the study: 3.5 - 5.3 mmol/L

    Measured: Single dose study:Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose study: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  46. Change in Serum calcium

    Measurement of the amount of calcium in the blood helps to diagnose an electrolyte imbalance caused by study drug. Changed calcium level (hypocalcaemia, hypercalcaemia) may influence the proper functioning of muscles, nerves, and the heart, coagulation, maintenance of bones and teeth.Calcium in the blood is measured in mmol/L. Normal range for the study: 2,15-2,55 mmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  47. Change in Serum magnesium

    Measurement of the amount of magnesium in the blood helps to diagnose an electrolyte imbalance caused by study drug. Abnormal levels of magnesium may influence the proper functioning of muscles, nerves, and the heart, helps control blood pressure and blood sugar. Low level of magnesium in the body may cause numerous symptoms: poor coordination, muscle spasms, loss of appetite, personality changes, and nystagmus. Magnesium in the blood is measured in mmol/L. Normal range for the study: 0,65- 1,5 mmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  48. Change in erythrocytes number in blood

    The influence of the study drug on the number and morphology of erythrocytes will be assessed. Normal range for the study: 3,9-5,5 х10^12 per liter.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  49. Change in hemoglobin

    The influence of the study drug on to the amount of hemoglobin will be assessed. Normal range for the study: 130-180 g/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  50. Change in leucocytes number in the blood

    The influence of the study drug on the number and morphology of leucocytes will be assessed. Normal range for the study: 4,0-9,0 х10^9 per liter.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  51. Change in thrombocytes number in the blood

    The influence of the study drug on the number and morphology of thrombocytes will be assessed. Normal range for the study: 180-400 х10^9 per liter.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  52. Change in hematocrit

    It is the percentage of red blood cells (RBC's) in the blood. The hematocrit test indicates the percentage of blood by volume that is composed of red blood cells. A hematocrit is measured in L/L (litre of cells per litre of blood). Normal range for the study: 36-55% .

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  53. Change in Erythrocyte Sedimentation Rate (ESR))

    ESR indirectly measures the degree of inflammation present in the body. The test actually measures the rate sedimentation of erythrocytes in a sample of blood that has been placed into a tall, thin, vertical tube. Results are reported as the millimeters of plasma that are present at the top portion of the tube after one hour. The ESR is non-specific test that provides general information about the presence or absence of an inflammatory condition. Normal range for the study: 2-10 mm/hour.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  54. Change in prothrombin index

    Measured in percents. Normal range for the study: 70-130 %

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 15;16;17;30;60;90

  55. Change in activated partial thromboplastin time (aPTT)

    Measured in seconds. Normal range for the study: 23-38 seconds

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 15;16;17;30;60;90

  56. Change in prothrombin ratio

    The ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the ISI value for the analytical system being used. Measured as a ratio. Normal range for the study:0,9-1,2

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 15;16;17;30;60;90

  57. Change in thrombin time

    Thrombin clotting time measures the time it takes for a clot to form in the plasma of a blood sample containing anticoagulant, after an excess of thrombin has been added.Measured in seconds. Normal range for the study:15-21 seconds

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 15;16;17;30;60;90

  58. Change of protein level in urine

    Proteinuria caused by study drug will be assessed. It may be due to kidney damage, heart failure, loss of body fluids (dehydration), high blood pressure. Protein level in urine is measured in mg/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  59. Change in Urinary glucose

    Glycosuria caused by study drug will be assessed. Measured in mmol/L Normal range for the study: 0 to 0.8 mmol/L.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  60. Hematuria

    Hematuria caused by study drug will be assessed.It is measured in the number of red blood cells per high-power field in microscopic investigation of urine sediment.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  61. Leucocyturia

    Leucocytes in urine after study drug intake will be assessed. Leucocyturia may be due to inflammation of the urinary track or adjacent tissue. It is measured in the number of white blood cells per high-power field in microscopic investigation of urine sediment.

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  62. Ketonuria

    Ketone bodies present in the urine after study drug intake will be assessed. It may be due to excess ketones production as an indication that the body is using an alternative source of energy. It is measured in mg/dL. A negative test result is normal.

    An abnormal result: small ketonuria: <20 mg/dL; moderate ketonuria: 30 to 40 mg/dL; large ketonuria: >80 mg/dL

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  63. Change in urine pH

    The influence of study drug on to urine pH will be evaluated. The normal values range from pH 4.6 to 8.0

    Measured: Single dose intake: Screening visit; before dose (Day -1); Day 1 - after dose (3 hours); Days 2;7;30;60. Multiple dose intake: Screening visit; before dose (Day -1); Days 1; 3;10;14-after dose (3 hours); Days 17;30;60;90

  64. Change in immunoglobulin A (IgA) level in blood

    The influence of study drug onto IgA level in blood will be evaluated. It is measured in g/L. Normal range for the study: 0,7-4,0 g/L.

    Measured: Single dose study: before dose (Day -1); Day 1 - after dose (3 hours); Day 2. Multiple dose study: before dose (Day -1) Days 14; 17; 30;60; 90

  65. Change in immunoglobulin M (IgM) level in blood

    The influence of study drug onto IgM level in blood will be evaluated. It is measured in g/L. Normal range for the study: 0,4-2,3 g/L.

    Measured: Single dose intake: before dose (Day -1); Day 1 - after dose (3 hours); Day 2. Multiple dose intake: before dose (Day -1) Days 14; 17; 30;60; 90

  66. Change in immunoglobulin G (IgG) level in blood

    The influence of study drug onto IgG level in blood will be evaluated. It is measured in g/L. Normal range for the study: 7-16 g/L.

    Measured: Single dose intake: before dose (Day -1); Day 1 - after dose (3 hours); Day 2. Multiple dose intake: before dose (Day -1) Days 14; 17; 30;60; 90

  67. Change in immunoglobulin E (IgE) level in blood

    The influence of study drug onto IgE level in blood will be evaluated. It is measured in IU/ml . Normal range for the study: 0,100-200,0 IU/ml.

    Measured: Single dose intake: Screening visit; Day 1 - after dose (3 hours); Day 2. Multiple dose intake: Screening visit; Days 14; 17; 30;60; 90

  68. Change in Rheumatoid factor

    The influence of study drug onto Rheumatoid factor in blood will be evaluated. It is measured in IU/ml . Normal range for the study: 0-25 IU/ml.

    Measured: Single dose intake: Screening visit; Day 1 - after dose (3 hours); Day 2. Multiple dose intake: Screening visit; Days 14; 17; 30;60; 90

  69. Change in C-Reactive Protein

    The influence of study drug onto C-Reactive Protein in blood will be evaluated. It is measured in mg/l . Normal range for the study: 0-5 mg/l

    Measured: Single dose intake: Screening visit; Day 1 - after dose (3 hours); Day 2. Multiple dose intake: Screening visit; Days 14; 17; 30;60; 90

  70. Change in Antimitochondrial Antibody

    The influence of study drug on Antimitochondrial Antibody in blood will be evaluated. It is measured in IU/ml. Normal range for the study: 0-10 IU/ml

    Measured: Single dose intake: before dose (Day -1); Day 30; Day 60. Multiple dose intake: before dose (Day -1); Day 60; Day90

  71. Change in antinuclear antibody

    The influence of study drug on antinuclear antibody in blood will be evaluated. It is measured in IU/ml. Normal range for the study: 0-40 IU/ml

    Measured: Single dose intake: before dose (Day -1); Day 30; Day 60. Multiple dose intake: before dose (Day -1); Day 60; Day90

  72. Change from baseline in CD3+tcells

    The influence of study drug on CD3+ tcells percent in blood will be evaluated. Normal range for the study: 52-76 %

    Measured: Single dose intake: before dose (Day -1); Day 1 - after dose (3 hours); Days 2; 17; 30; 60. Multiple dose intake: before dose (Day -1); Day 1; 14 - after dose (3 hours); Days 17;30;60;90

  73. Change from baseline in CD4+tcells

    The influence of study drug on CD4+ tcells percent in blood will be evaluated. Normal range for the study: 31-46 %

    Measured: Single dose intake: before dose (Day -1); Day 1 - after dose (3 hours); Days 2; 17; 30; 60. Multiple dose intake: before dose (Day -1); Day 1; 14 - after dose (3 hours); Days 17;30;60;90

  74. Change from baseline in CD8+tcells

    The influence of study drug on CD8+ tcells percent in blood will be evaluated. Normal range for the study: 23-40 %

    Measured: Single dose intake: before dose (Day -1); Day 1 - after dose (3 hours); Days 2; 17; 30; 60. Multiple dose intake: before dose (Day -1); Day 1; 14 - after dose (3 hours); Days 17;30;60;90

  75. Change from baseline in Ratio CD4/CD8

    The influence of study drug on Ratio CD4/CD8 in blood will be evaluated. Normal range for the study: 1.2-2.0 %

    Measured: Single dose intake: before dose (Day -1); Day 1 - after dose (3 hours); Days 2; 17; 30; 60. Multiple dose intake: before dose (Day -1); Day 1; 14 - after dose (3 hours); Days 17;30;60;90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2019
  2. Study start17 Jun 2016
  3. Primary completion15 May 2019
  4. Study completion15 Sep 2019

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04174937
Sponsor's protocol ID
PA-001
Acronym
PA
Status last verified
Nov 2019
First submitted
7 Dec 2017
Last updated
22 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Potentiator of antibiotics (PA) in people with Infections, Respiratory, run by Scientific Center for Anti-infectious Drugs, Kazakhstan at 1 site in Kazakhstan.

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 6 inclusion and 8 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 22 Nov 2019. 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 Kazakhstan. 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?

Adverse Events (AE) (time frame: Adverse event reporting will be performed throughout the trial from the Screening visit until the Final visit (up to 90 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04174937.

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 22 Nov 2019.

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