TuberculosisPhase 1NCT03036163
Phase 1 Study of PBTZ169
A Phase 1 study testing PBTZ169 - 40 mg, PBTZ169 - 80 mg and PBTZ169 - 160 mg in people with Tuberculosis, run by Nearmedic Plus LLC.
Trial summary
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- PBTZ169 - 40 mg, PBTZ169 - 80 mg and PBTZ169 - 160 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent received from a volunteer.
- Man aged 18 to 45 years old, inclusive.
- Body mass index of 18.5-25 kg/m2.
- Verified diagnosis: "healthy" according to data of standard clinical, laboratory and instrumental examination methods performed at screening:
- Absence of deviations of physical examination parameters and vital signs (systolic blood pressure - 100-129 mm Hg, inclusive; diastolic blood pressure - 70-89 mm Hg, inclusive; heart rate - 60-80 bpm, inclusive);
- Absence of deviations of laboratory parameters (complete blood count, blood biochemistry, urinalysis and tests for HIV, HBV, HCV, syphilis);
Show all 13Show fewer
- Normal parameters of 12-lead ECG;
- Normal results of photofluorographic or X-ray examination (the results received maximum 6 months before screening can be used).
- 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:
- female partner using hormonal contraception;
- using aerosols, creams, suppositories and other agents containing spermicides;
- female partner using intrauterine device
Who cannot join
- Aggravated allergic history, including presence of at least one episode of drug allergy.
- Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine systems, ENT and gastrointestinal, hepatic, renal, blood and cutaneous diseases.
- Chronic diseases of eyes except for mild to moderate myopia, hypermetropia and astigmatism.
- Gastrointestinal surgeries (except for appendectomy performed not less than 1 year before screening).
- Acute infections within less than 4 weeks before screening.
- Regular drug administration within less than 4 weeks before screening.
Show all 16Show fewer
- Regular administration or application (including topical) of hormonal drugs for more than 1 week within less than 45 days before the screening.
- Administration of drugs exerting evident effects on hemodynamics, hepatic function, etc. (barbiturates, omeprazole, cimetidine, etc.) within less than 45 days before the screening.
- Positive tests for narcotic and psychotropic agents.
- Donation (450 mL of blood or plasma) within less than 3 months before the screening.
- Intake of more than 10 U of alcohol per week (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of vine or 50 mL of strong alcoholic drink) or historical data on alcoholism, narcomania, drug abuse.
- Mental illnesses.
- Smoking within half a year before the screening.
- Previous participation in this clinical study and withdrawal from it due to any reason.
- Participation in other clinical studies of drugs within less than 6 months before the screening.
- Planned conception or sperm donation during the study after the test drug administration or during 3 months after the date of drug administration.
About this study
Official title: Open-label Prospective Noncomparative Study of Safety, Tolerability and Pharmacokinetics of PBTZ169 After Single and Multiple Fasting Oral Administration in Increasing Doses in Healthy Volunteers
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
Read the detailed description
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in adult man healthy volunteers after single and multiple oral fasting administration. Study was conducted in one study center in Russian Federation. The study included two stages:
- Stage 1 - single oral fasting administration with dose escalation in 5 cohorts 6 healthy man volunteers each in main groups (plus 1 back-up volunteer in every group);
- Stage 2 - multiple oral fasting administration with dose escalation in 2 cohorts 6 healthy man volunteers each in main groups (plus 1 back-up volunteer in every group).
Screening procedures for each cohort performed within 7 days before the drug prescription and after the end of administration period in previous cohort. Screening in cohorts 2 and 6 was started only after safety tolerability and PK data analysis of previous cohorts.
All volunteers met the study inclusion/exclusion criteria was included successively into the following cohorts on Stage 1 (actual data):
- Cohort 1 (C1) - 6 volunteers of the main group each of whom received once single dose of the drug - 1 capsule containing 40 mg of PBTZ169;
- Cohort 2 (C2) - 6 volunteers of the main group each of whom received once 80 mg of PBTZ169 (2 capsules 40 mg);
- Cohort 3 (C3) - 6 volunteers of the main group each of whom received once 160 mg of PBTZ169 (4 capsules 40 mg);
- Cohort 4 (C4) - 6 volunteers of the main group each of whom received once 320 mg of PBTZ169 (8 capsules 40 mg);
- Cohort 5 (C5) - 6 volunteers of the main group each of whom received once 640 mg of PBTZ169 (16 capsules 40 mg).
On Stage 2 (actual data):
- Cohort 6 (C6) - 5 volunteers of the main group each of whom received 320 mg of PBTZ169 (8 capsules 40 mg) once daily for 14 days;
- Cohort 7 (C7) - 5 volunteers of the main group each of whom received 640 mg of PBTZ169 (16 capsules 40 mg) once daily for 14 days.
Safety was assessed throughout the study. For every volunteer series of urine and venous blood samples was collected for the safety, tolerability and PK assessment of PBTZ169.
- Conditions
- Tuberculosis
- Being tested
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg, PBTZ169 - 320 mg, PBTZ169 - 640 mg
- Keywords
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBTZ169 - 40 mgDrug
Also called PBTZ169
40 mg of PBTZ169 (1 capsule) orally once in fasting state
PBTZ169 - 80 mgDrug
Also called PBTZ169
80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
PBTZ169 - 160 mgDrug
Also called PBTZ169
160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
PBTZ169 - 320 mgDrug
Also called PBTZ169
320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
PBTZ169 - 640 mgDrug
Also called PBTZ169
640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
PBTZ169 - 320 mg (multiple administration)Drug
Also called PBTZ169
320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
PBTZ169 - 640 mg (multiple administration)Drug
Also called PBTZ169
640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule) Receives: Drug: PBTZ169 - 40 mg |
| Cohort 2 | Experimental | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules) Receives: Drug: PBTZ169 - 80 mg |
| Cohort 3 | Experimental | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules) Receives: Drug: PBTZ169 - 160 mg |
| Cohort 4 | Experimental | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules) Receives: Drug: PBTZ169 - 320 mg |
| Cohort 5 | Experimental | 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules) Receives: Drug: PBTZ169 - 640 mg |
| Cohort 6 | Experimental | 5 male healthy volunteers each of whom received once daily for 14 days 320 mg of PBTZ169 (8 capsules 40 mg) Receives: Drug: PBTZ169 - 320 mg (multiple administration) |
| Cohort 7 | Experimental | 5 male healthy volunteers each of whom received once daily for 14 days 640 mg of PBTZ169 (16 capsules 40 mg) Receives: Drug: PBTZ169 - 640 mg (multiple administration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Drug-related Adverse Events [Safety and Tolerability]
The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted
Measured: 14±1 days after the drug administration (up to last visit time point)
Secondary outcomes (15)
Peak Plasma Concentration (Сmax) of PBTZ169
Up to 72 hours after the last drug administration:
Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)
Measured: Up to 72 hours after the last drug administration
Time to Reach Maximum Concentration (Tmax) of PBTZ169
Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)
Measured: Up to 72 hours after the last drug administration
Area Under the Concentration-time Curve (AUC0-∞)
In the time interval from 0 to infinity
Measured: Up to 72 hours after the last drug administration
Plasma Half-life Time (T1/2) of PBTZ169
Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)
Measured: Up to 72 hours after the last drug administration
Mean Plasma Retention Time (MRT) of PBTZ169
Measured: Up to 72 hours after the last drug administration
Total (Plasma) Clearance (Cl) of PBTZ169
The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ
Measured: Up to 72 hours after the last drug administration
Volume of Distribution (Vd) of PBTZ169
Measured: Up to 72 hours after the last drug administration
Elimination Constant (Kel) of PBTZ169
Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) \& 640 mg (Cohorts 5 and 7, total 11 volunters) were combined
Measured: Up to 72 hours after the last drug administration
Renal Clearance (Clren) of PBTZ169
The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)
Measured: Up to 24 hours after the drug administration
Peak Steady State Plasma Concentration (Cmax,ss) of PBTZ169
For cohorts 6 and 7 (multiple administration) only
Measured: Up to 72 hours after the last drug administration
Time to Reach Maximum Steady State Concentration (Tmax,ss) of PBTZ169
For cohorts 6 and 7 (multiple administration) only
Measured: Up to 72 hours after the last drug administration
Area Under the Plasma Concentration Versus Time Curve in Steady State (AUCss) of PBTZ169
For cohorts 6 and 7 (multiple administration) only
Measured: Up to 72 hours after the last drug administration
Volume of Steady State Distribution (Vd,ss) of PBTZ169
For cohorts 6 and 7 (multiple administration) only
Measured: Up to 72 hours after the last drug administration
Area Under the Concentration-time Curve (AUC0-t)
The area under the concentration-time curve from 0 to last blood sampling
Measured: Up to 72 hours after the last drug administration
AUC0-t/AUC0-∞
AUC0-t/AUC0-∞ ratio
Measured: Up to 72 hours after the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nearmedic Plus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OCT LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036163
- Sponsor's protocol ID
- PBTZ169-Z00-C01-1
- Status last verified
- Mar 2020
- First submitted
- 14 Sep 2016
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Prospective Noncomparative Study of Safety, Tolerability and Pharmacokinetics of PBTZ169 After Single and Multiple Fasting Oral Administration in Increasing Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03036163
- Acronym / sponsor ID
- PBTZ169-Z00-C01-1
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nearmedic Plus LLCIndustry (pharma, biotech, devices)
- Collaborators
- OCT LLC
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
Detailed description
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in adult man healthy volunteers after single and multiple oral fasting administration. Study was conducted in one study center in Russian Federation. The study included two stages:
- Stage 1 - single oral fasting administration with dose escalation in 5 cohorts 6 healthy man volunteers each in main groups (plus 1 back-up volunteer in every group);
- Stage 2 - multiple oral fasting administration with dose escalation in 2 cohorts 6 healthy man volunteers each in main groups (plus 1 back-up volunteer in every group).
Screening procedures for each cohort performed within 7 days before the drug prescription and after the end of administration period in previous cohort. Screening in cohorts 2 and 6 was started only after safety tolerability and PK data analysis of previous cohorts.
All volunteers met the study inclusion/exclusion criteria was included successively into the following cohorts on Stage 1 (actual data):
- Cohort 1 (C1) - 6 volunteers of the main group each of whom received once single dose of the drug - 1 capsule containing 40 mg of PBTZ169;
- Cohort 2 (C2) - 6 volunteers of the main group each of whom received once 80 mg of PBTZ169 (2 capsules 40 mg);
- Cohort 3 (C3) - 6 volunteers of the main group each of whom received once 160 mg of PBTZ169 (4 capsules 40 mg);
- Cohort 4 (C4) - 6 volunteers of the main group each of whom received once 320 mg of PBTZ169 (8 capsules 40 mg);
- Cohort 5 (C5) - 6 volunteers of the main group each of whom received once 640 mg of PBTZ169 (16 capsules 40 mg).
On Stage 2 (actual data):
- Cohort 6 (C6) - 5 volunteers of the main group each of whom received 320 mg of PBTZ169 (8 capsules 40 mg) once daily for 14 days;
- Cohort 7 (C7) - 5 volunteers of the main group each of whom received 640 mg of PBTZ169 (16 capsules 40 mg) once daily for 14 days.
Safety was assessed throughout the study. For every volunteer series of urine and venous blood samples was collected for the safety, tolerability and PK assessment of PBTZ169.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PBTZ169 - 40 mg6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule) |
| Cohort 2 | Experimental | Drug: PBTZ169 - 80 mg6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules) |
| Cohort 3 | Experimental | Drug: PBTZ169 - 160 mg6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules) |
| Cohort 4 | Experimental | Drug: PBTZ169 - 320 mg6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules) |
| Cohort 5 | Experimental | Drug: PBTZ169 - 640 mg6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules) |
| Cohort 6 | Experimental | Drug: PBTZ169 - 320 mg (multiple administration)5 male healthy volunteers each of whom received once daily for 14 days 320 mg of PBTZ169 (8 capsules 40 mg) |
| Cohort 7 | Experimental | Drug: PBTZ169 - 640 mg (multiple administration)5 male healthy volunteers each of whom received once daily for 14 days 640 mg of PBTZ169 (16 capsules 40 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Written informed consent received from a volunteer.
- Man aged 18 to 45 years old, inclusive.
- Body mass index of 18.5-25 kg/m2.
- Verified diagnosis: "healthy" according to data of standard clinical, laboratory and instrumental examination methods performed at screening:
- Ability, according to investigators opinion, to comply with all requirements of the protocol.
Key exclusion criteria (16 listed)
- Aggravated allergic history, including presence of at least one episode of drug allergy.
- Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine systems, ENT and gastrointestinal, hepatic, renal, blood and cutaneous diseases.
- Chronic diseases of eyes except for mild to moderate myopia, hypermetropia and astigmatism.
- Gastrointestinal surgeries (except for appendectomy performed not less than 1 year before screening).
- Acute infections within less than 4 weeks before screening.
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 |
|---|---|---|
| PBTZ169 - 40 mgAlso: PBTZ16940 mg of PBTZ169 (1 capsule) orally once in fasting state | Drug | Cohort 1 |
| PBTZ169 - 80 mgAlso: PBTZ16980 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state | Drug | Cohort 2 |
| PBTZ169 - 160 mgAlso: PBTZ169160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state | Drug | Cohort 3 |
| PBTZ169 - 320 mgAlso: PBTZ169320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state | Drug | Cohort 4 |
| PBTZ169 - 640 mgAlso: PBTZ169640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state | Drug | Cohort 5 |
| PBTZ169 - 320 mg (multiple administration)Also: PBTZ169320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days | Drug | Cohort 6 |
| PBTZ169 - 640 mg (multiple administration)Also: PBTZ169640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days | Drug | Cohort 7 |
Primary outcome
Incidence of Drug-related Adverse Events [Safety and Tolerability]
Time frame: 14±1 days after the drug administration (up to last visit time point)
The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted
15 secondary outcomes
Peak Plasma Concentration (Сmax) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Time to Reach Maximum Concentration (Tmax) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Area Under the Concentration-time Curve (AUC0-∞)
Time frame: Up to 72 hours after the last drug administration
Plasma Half-life Time (T1/2) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Mean Plasma Retention Time (MRT) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Total (Plasma) Clearance (Cl) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Volume of Distribution (Vd) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Elimination Constant (Kel) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Renal Clearance (Clren) of PBTZ169
Time frame: Up to 24 hours after the drug administration
Peak Steady State Plasma Concentration (Cmax,ss) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Time to Reach Maximum Steady State Concentration (Tmax,ss) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Area Under the Plasma Concentration Versus Time Curve in Steady State (AUCss) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Volume of Steady State Distribution (Vd,ss) of PBTZ169
Time frame: Up to 72 hours after the last drug administration
Area Under the Concentration-time Curve (AUC0-t)
Time frame: Up to 72 hours after the last drug administration
AUC0-t/AUC0-∞
Time frame: Up to 72 hours after the last drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Tuberculosis (TB)
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBTZ169 - 40 mg, PBTZ169 - 80 mg and PBTZ169 - 160 mg in people with Tuberculosis, run by Nearmedic Plus 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 13 inclusion and 16 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 13 Apr 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. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Drug-related Adverse Events [Safety and Tolerability] (time frame: 14±1 days after the drug administration (up to last visit time point)). 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 13 Apr 2020.