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Very slow enrollment
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| Name | Class |
|---|---|
| OCT LLC | INDUSTRY |
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Multicenter, open, randomized study with active control (isoniazid) to evaluate the early antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when used in patients with first-diagnosed tuberculosis of the respiratory system with bacterial excretion and saved bacterial susceptibility to isoniazid and rifampicin
This phase 2a study is aimed to evaluate the early bactericidal activity of a new anti-tuberculosis drug PBTZ169 (capsules 80 mg), and its results will allow preliminary evaluate antimycobacterial properties of PBTZ169 and confirm a potentially more effective dose for subsequent studies. This study is an open, randomized comparative efficacy (on the parameter of early bactericidal activity), safety and pharmacokinetics study of PBTZ169 in patients with first-diagnosed lung tuberculosis and preserved sensitivity to base antimycobacterial drugs: rifampicin and isoniazid.
Within the framework of the study, it is planned to use the studied drugs (PBTZ169 and isoniazid) as monotherapy within 14 days. Isoniazid is used as a "positive control", that is, in order to determine whether the method of assessing efficacy on the parameter of early bactericidal activity is working.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBTZ169, 160 mg | Experimental | 2 capsules 80 mg of PBTZ169 once a day for 14 days |
|
| PBTZ169, 320 mg | Experimental | 4 capsules 80 mg of PBTZ169 once a day for 14 days |
|
| PBTZ169, 640 mg | Experimental | 8 capsules 80 mg of PBTZ169 once a day for 14 days |
|
| Isoniazid, 600 mg | Active Comparator | 2 tablets 300 mg of Isoniazid once a day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBTZ169 | Drug | Once a day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Bactericidal Activity (0-14) | Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): agar inoculation, the mean of two measurements at the Visit | 14 days after the onset of monotherapy |
| Early Bactericidal Activity (0-14) | Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): PCR, the mean of two measurements at the Visit | 14 days after the onset of monotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Early Bactericidal Activity (0-2) | EBA (0-2): agar inoculation, the mean of two measurements at the Visit | 2 days after the onset of monotherapy |
| Early Bactericidal Activity (0-7) | EBA (0-7): agar inoculation, the mean of two measurements at the Visit |
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Inclusion Criteria:
Written informed consent received from a volunteer
Men and women aged 18 to 65 years, inclusive
The first-diagnosed active pulmonary tuberculosis, confirmed by characteristic radiographic changes (infiltration, dissemination, destruction) during radiography or computed tomography of chest organs, without damage to other organs or with the defeat of one or more of the following organs: larynx, trachea, bronchi, lymph nodes
The amount of sputum given by the patient is sufficient for carrying out the analyzes provided for by the protocol, but not less than 4-5 ml at the screening
The presence of acid-fast mycobacteria in the sputum according to the results of microscopy of smears (1+ and more using the method of microscopy with luminescent dye staining according to the Order of the Ministry of Health of the Russian Federation of March 21, 2003 No. 109, the last edition) and the detection of the DNA of mycobacteria of tuberculosis by the results of molecular genetic methods of diagnosis
Body weight not less than 51 kg
Body mass index of 18.5-25 kg/m2
Ability, according to investigators opinion, to comply with all requirements of the protocol
Agreement to use double contraception method during the study participation and for 3 months after the test drug administration - combination of male condom with not less than one of the following methods:
Exclusion Criteria:
Extrapulmonary localization of tuberculosis
Presence of resistance to rifampicin and / or isoniazid in the study of sputum samples using molecular genetic methods
Admission of any anti-tuberculosis drugs from the moment of diagnosis of tuberculosis to the moment of inclusion in the study
The presence of absolute indications for surgical treatment of tuberculosis at the time of screening
Positive tests for serological markers of syphilis or HIV infection during screening; active hepatitis or decompensated hepatic cirrhosis
Aggravated allergic history, including presence of at least one episode of drug allergy
The values of renal and / or hepatic parameters according to laboratory analyzes (taking into account the range of normal laboratory values):
Individual drug components intolerance
Presence in the anamnesis of malignant neoplasms, except for basal cell skin cancer
The presence of severe chronic somatic diseases in the stage of decompensation, including diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, ear, nose and throat (ENT) organs, the gastrointestinal tract, liver, kidneys, blood, skin, or any other somatic or mental diseases that, according to the researcher, prevent the patient from entering the study
Gastrointestinal surgeries (except for appendectomy performed not less than 1 year before screening)
Mental illness that may interfere with the patient's compliance with the protocol
Diabetes mellitus
Acute viral and bacterial infections at the time of enrollment or within 2 weeks before enrollment
Alcoholism (except in cases when the patient is able, in the opinion of the researcher, to refrain from taking alcohol during the period of participation in the study), drug addiction, abuse of medicines
Positive tests for narcotic and psychotropic agents
Regular admission or use (including externally) of any hormonal medicines lasting more than 1 week less than 30 days before screening (with the exception of oral hormonal contraceptives and intrauterine spirals containing hormones)
Use of cytostatic drugs less than 30 days before screening
Multiple admission of drugs with the described in the instructions for medical use adverse events related to nervous system, hemodynamic and hepatic functions with frequencies "very frequent" (≥10%) and "often" (≥1% and <10%) less than 21 days before screening
Pregnancy or lactation period
Planned conception or sperm donation during the study after the test drug administration or during 3 months after the last date of drug administration
Participation in other clinical studies of drugs within less than 3 months before the screening
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| ID | Title | Description |
|---|---|---|
| FG000 | PBTZ169, 160 mg | 2 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| FG001 | PBTZ169, 320 mg | 4 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| FG002 | PBTZ169, 640 mg | 8 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| FG003 | Isoniazid, 600 mg | 2 tablets 300 mg of Isoniazid once a day for 14 days Isoniazid: Once a day for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PBTZ169, 160 mg | 2 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| BG001 | PBTZ169, 320 mg | 4 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Bactericidal Activity (0-14) | Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): agar inoculation, the mean of two measurements at the Visit | FAS | Posted | Mean | Standard Deviation | CFU per 1 mL of sputum | 14 days after the onset of monotherapy |
|
Collection and evaluation of safety data started at the Screening Visit (Day -10 to -1) after signing the informed consent form and was continued till the last visit of the patient within the study (Day 21+1)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PBTZ169, 160 mg | 2 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneously opened tuberculous paraproctitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viсtoria Shcherbakova | Nearmedic Plus | +7 (495) 741 49 89 | 3869 | Viktoriya.Shcherbakova@nearmedic.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2017 | Feb 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C000592783 | macozinone |
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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| Isoniazid | Drug | Once a day for 14 days |
|
| 7 days after the onset of monotherapy |
| Early Bactericidal Activity (0-2) | EBA (0-2): PCR, the mean of two measurements at the Visit | 2 days after the onset of monotherapy |
| Early Bactericidal Activity (0-7) | EBA (0-7): PCR, the mean of two measurements at the Visit | 7 days after the onset of monotherapy |
| Peak Plasma Concentration (Сmax) of PBTZ169 | Peak plasma concentration (Сmax) of PBTZ169 for multiple dosing | Up to 72 hours after the last drug administration |
| Minimal Plasma Concentration (Сmin) of PBTZ169 | Minimal plasma concentration (Сmin) of PBTZ169: concentration measurement following single dosing | for single dosing , Day 1 (24 h after 1st dose of PBTZ169) |
| Residual Concentration (Ctrough) of PBTZ169 | Residual concentration (Ctrough) of PBTZ169, measured 24 hours after the first dose administration, prior to the last dose, and 24 hours after the last dose | Up to 72 hours after the last drug administration |
| Minimal Plasma Concentration (Сmin) of PBTZ169 | Minimal plasma concentration (Сmin) of PBTZ169: multiple dosing | Up to 72 hours after the last drug administration |
| Time to Reach Maximum Concentration (Tmax) of PBTZ169 | Time to reach maximum concentration (Tmax) of PBTZ169 after single oral administration in different doses | for single dosing , Day 1 (24 h after 1st dose of PBTZ169) |
| Time to Reach Maximum Concentration (Tmax) of PBTZ169 | Time to reach maximum concentration (Tmax) of PBTZ169 after multiple oral administration in different doses | Up to 72 hours after the last drug administration |
| AUC(0-24) | Area under the plasma concentration of PBTZ169 versus time curve in frames [0-24 hours] | Up to 24 hours after the first drug administration |
| Peak Plasma Concentration (Сmax) of PBTZ169 | Peak plasma concentration (Сmax) of PBTZ169: concentration measurement following single dosing | for single dosing , Day 1 (24 h after 1st dose of PBTZ169) |
| AUC(0-24) | Area under the plasma concentration of PBTZ169 versus time curve in frames [0-24 hours] for the last dosing (Day 14) | Up to 24 hours after the last drug administration |
| AUC (0-t) | Area under the plasma concentration of PBTZ169 versus time curve in frames [0-last concentration above lower limit of quantification (LLoQ)] | Up to 72 hours after the last drug administration |
| AUC(0-∞) of PBTZ169 | Area under the plasma concentration versus time curve in frames [0-∞] | Up to 72 hours after the last drug administration |
| Accumulation Ratios for the PK Parameters AUC(0 -24) | Accumulation ratios for the PK parameter AUC(0 -24): AUC(0- 24,ss)/AUC(0 -24), Day 1, on the original scale | 24 hours after the first and the last drug administration |
| Average Concentration (Css,av) of PBTZ169 | Average steady-state concentration in the dosing interval following multiple dosing was evaluated as the ratio AUC0 24/τ (τ = the dosing interval) | Up to 72 hours after the last drug administration |
| Fluctuations (%) in the Dosing Interval | Fluctuations (%) in the dosing interval after multiple dosing ((Cmax - Cmin) × 100%/Css,av) | Up to 72 hours after the last drug administration |
| Total (Plasma) Clearance (Clt) of PBTZ169 | Clt/F (apparent total clearance following single and multiple oral administration) was calculated using the following formula: Cl_t/F=D/AUC where D is the daily dose of the drug. | 24 hours after the first drug administration |
| Total (Plasma) Clearance (Clt) of PBTZ169 | Clt/F (apparent total clearance following single and multiple oral administration) was calculated using the following formula: Cl_t/F=D/AUC where D is the daily dose of the drug. | 24 hours after the last drug administration |
| Volume of Distribution (Vd) of PBTZ169 | Distribution volume Vd for a dosing interval of 72 hours after the last dose | Up to 72 hours after the last drug administration |
| Plasma Half-life Time (T1/2) of PBTZ169 | 24 hours after the fist drug administration |
| Plasma Half-life Time (T1/2) of PBTZ169 | 24 hours after the last drug administration |
| Elimination Constant (Kel) of PBTZ169 | Apparent terminal elimination rate constant was evaluated based on the regressional dependence of log-transformed concentrations ln(C) on time for the terminal log- linear part of the concentration-time curve. | 24 hours after the first drug administration |
| Elimination Constant (Kel) of PBTZ169 | Apparent terminal elimination rate constant was evaluated based on the regressional dependence of log-transformed concentrations ln(C) on time for the terminal log- linear part of the concentration-time curve. | 72 hours after the last drug administration |
| BG002 | PBTZ169, 640 mg | 8 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| BG003 | Isoniazid, 600 mg | 2 tablets 300 mg of Isoniazid once a day for 14 days Isoniazid: Once a day for 14 days |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PBTZ169, 640 mg |
8 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days |
| OG003 | Isoniazid, 600 mg | 2 tablets 300 mg of Isoniazid once a day for 14 days Isoniazid: Once a day for 14 days |
|
|
| Primary | Early Bactericidal Activity (0-14) | Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): PCR, the mean of two measurements at the Visit | FAS | Posted | Mean | Standard Deviation | cell count per 1 mL of sputum | 14 days after the onset of monotherapy |
|
|
|
| Secondary | Early Bactericidal Activity (0-2) | EBA (0-2): agar inoculation, the mean of two measurements at the Visit | FAS | Posted | Mean | Standard Deviation | CFU per 1 mL of sputum | 2 days after the onset of monotherapy |
|
|
|
| Secondary | Early Bactericidal Activity (0-7) | EBA (0-7): agar inoculation, the mean of two measurements at the Visit | FAS | Posted | Mean | Standard Deviation | CFU per 1 mL of sputum | 7 days after the onset of monotherapy |
|
|
|
| Secondary | Early Bactericidal Activity (0-2) | EBA (0-2): PCR, the mean of two measurements at the Visit | FAS | Posted | Mean | Standard Deviation | cell count per 1 mL of sputum | 2 days after the onset of monotherapy |
|
|
|
| Secondary | Early Bactericidal Activity (0-7) | EBA (0-7): PCR, the mean of two measurements at the Visit | FAS | Posted | Mean | Standard Deviation | cell count per 1 mL of sputum | 7 days after the onset of monotherapy |
|
|
|
| Secondary | Peak Plasma Concentration (Сmax) of PBTZ169 | Peak plasma concentration (Сmax) of PBTZ169 for multiple dosing | PKA: the pharmacokinetic analysis population for multiple dosing comprised all patients participating in the PK study who had received at least one dose of the study drug PBTZ169, provided that data on study drug concentration (with at least one measurement above BLQ) was available. | Posted | Mean | Standard Deviation | ng/ml | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Minimal Plasma Concentration (Сmin) of PBTZ169 | Minimal plasma concentration (Сmin) of PBTZ169: concentration measurement following single dosing | PKA | Posted | Mean | Standard Deviation | ng/ml | for single dosing , Day 1 (24 h after 1st dose of PBTZ169) |
|
|
|
| Secondary | Residual Concentration (Ctrough) of PBTZ169 | Residual concentration (Ctrough) of PBTZ169, measured 24 hours after the first dose administration, prior to the last dose, and 24 hours after the last dose | PKA | Posted | Mean | Standard Deviation | ng/ml | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Minimal Plasma Concentration (Сmin) of PBTZ169 | Minimal plasma concentration (Сmin) of PBTZ169: multiple dosing | PKA | Posted | Mean | Standard Deviation | ng/ml | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Time to Reach Maximum Concentration (Tmax) of PBTZ169 | Time to reach maximum concentration (Tmax) of PBTZ169 after single oral administration in different doses | PKA | Posted | Median | Full Range | h | for single dosing , Day 1 (24 h after 1st dose of PBTZ169) |
|
|
|
| Secondary | Time to Reach Maximum Concentration (Tmax) of PBTZ169 | Time to reach maximum concentration (Tmax) of PBTZ169 after multiple oral administration in different doses | PKA | Posted | Median | Full Range | h | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | AUC(0-24) | Area under the plasma concentration of PBTZ169 versus time curve in frames [0-24 hours] | PKA | Posted | Mean | Standard Deviation | ng*h/ml | Up to 24 hours after the first drug administration |
|
|
|
| Secondary | Peak Plasma Concentration (Сmax) of PBTZ169 | Peak plasma concentration (Сmax) of PBTZ169: concentration measurement following single dosing | PKA: the pharmacokinetic analysis population for multiple dosing comprised all patients participating in the PK study who had received at least one dose of the study drug PBTZ169, provided that data on study drug concentration (with at least one measurement above BLQ) was available. | Posted | Mean | Standard Deviation | ng/ml | for single dosing , Day 1 (24 h after 1st dose of PBTZ169) |
|
|
|
| Secondary | AUC(0-24) | Area under the plasma concentration of PBTZ169 versus time curve in frames [0-24 hours] for the last dosing (Day 14) | PKA | Posted | Mean | Standard Deviation | ng*h/ml | Up to 24 hours after the last drug administration |
|
|
|
| Secondary | AUC (0-t) | Area under the plasma concentration of PBTZ169 versus time curve in frames [0-last concentration above lower limit of quantification (LLoQ)] | PKA | Posted | Mean | Standard Deviation | ng*h/ml | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | AUC(0-∞) of PBTZ169 | Area under the plasma concentration versus time curve in frames [0-∞] | PKA | Posted | Mean | Standard Deviation | ng*h/ml | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Accumulation Ratios for the PK Parameters AUC(0 -24) | Accumulation ratios for the PK parameter AUC(0 -24): AUC(0- 24,ss)/AUC(0 -24), Day 1, on the original scale | PKA | Posted | Geometric Mean | 90% Confidence Interval | ratio | 24 hours after the first and the last drug administration |
|
|
|
| Secondary | Average Concentration (Css,av) of PBTZ169 | Average steady-state concentration in the dosing interval following multiple dosing was evaluated as the ratio AUC0 24/τ (τ = the dosing interval) | PKA | Posted | Mean | Standard Deviation | ng/ml | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Fluctuations (%) in the Dosing Interval | Fluctuations (%) in the dosing interval after multiple dosing ((Cmax - Cmin) × 100%/Css,av) | PKA | Posted | Mean | Standard Deviation | % (ratio) | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Total (Plasma) Clearance (Clt) of PBTZ169 | Clt/F (apparent total clearance following single and multiple oral administration) was calculated using the following formula: Cl_t/F=D/AUC where D is the daily dose of the drug. | PKA | Posted | Mean | Standard Deviation | L/h | 24 hours after the first drug administration |
|
|
|
| Secondary | Total (Plasma) Clearance (Clt) of PBTZ169 | Clt/F (apparent total clearance following single and multiple oral administration) was calculated using the following formula: Cl_t/F=D/AUC where D is the daily dose of the drug. | PKA | Posted | Mean | Standard Deviation | L/h | 24 hours after the last drug administration |
|
|
|
| Secondary | Volume of Distribution (Vd) of PBTZ169 | Distribution volume Vd for a dosing interval of 72 hours after the last dose | PKA | Posted | Mean | Standard Deviation | L | Up to 72 hours after the last drug administration |
|
|
|
| Secondary | Plasma Half-life Time (T1/2) of PBTZ169 | PKA | Posted | Mean | Standard Deviation | h | 24 hours after the fist drug administration |
|
|
|
| Secondary | Plasma Half-life Time (T1/2) of PBTZ169 | PKA | Posted | Mean | Standard Deviation | h | 24 hours after the last drug administration |
|
|
|
| Secondary | Elimination Constant (Kel) of PBTZ169 | Apparent terminal elimination rate constant was evaluated based on the regressional dependence of log-transformed concentrations ln(C) on time for the terminal log- linear part of the concentration-time curve. | PKA | Posted | Mean | Standard Deviation | 1/h | 24 hours after the first drug administration |
|
|
|
| Secondary | Elimination Constant (Kel) of PBTZ169 | Apparent terminal elimination rate constant was evaluated based on the regressional dependence of log-transformed concentrations ln(C) on time for the terminal log- linear part of the concentration-time curve. | PKA | Posted | Mean | Standard Deviation | 1/h | 72 hours after the last drug administration |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | PBTZ169, 320 mg | 4 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days | 0 | 4 | 0 | 4 | 3 | 4 |
| EG002 | PBTZ169, 640 mg | 8 capsules 80 mg of PBTZ169 once a day for 14 days PBTZ169: Once a day for 14 days | 0 | 7 | 1 | 7 | 2 | 7 |
| EG003 | Isoniazid, 600 mg | 2 tablets 300 mg of Isoniazid once a day for 14 days Isoniazid: Once a day for 14 days | 0 | 1 | 0 | 1 | 0 | 1 |
| Sinus tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Wandering atrial pacemaker | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fever | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Metabolic disorders found in ECG | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| QTc elongation | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| QTc(F) shortening | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Repolarization disturbances in the V1 lead in ECG | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Reduced (+)T amplitude in standard leads | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| ESR over 2.5 x normal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The agreements between the Principal Investigators and the CRO restricts the PIs' rights to discuss or publish trial results after the trial is completed.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
|
| 24 hours after the last dose (Ctrough_MD24) |
|