Healthy SubjectsPhase 1NCT04150224

Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169

A Phase 1 study testing PBTZ169 640 mg OD, PBTZ169 640 mg BiD and PBTZ169 960 mg SD in people with Healthy Subjects, run by Nearmedic Plus LLC at 1 site in Russia.

Completed

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

Official record

Search all trials

Trial summary

Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: PBTZ169 640 mg OD, PBTZ169 640 mg BiD and PBTZ169 960 mg SD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteRussia
Study dates: 3 Jul 2018to 1 Feb 2019
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Written informed consent from the volunteer.
Men and women aged 18-45 years, inclusive.
Body mass index of 18.5-30 kg/m2.
Verified "healthy" diagnosis based on physical examination, vital signs, standard laboratory tests (complete blood count and biochemical blood test, urine analysis) and instrumental tests (ECG, fluorography examination or X-ray examination).
Negative results of tests for human immunodeficiency virus (HIV), syphilis, hepatitis B (Hbs Ag) and hepatitis C (antibodies to HCV).
Ability to comply with all the requirements of the protocol in the opinion of the investigator.

Show all 10Show fewer

Consent of the participant and his/her partner to use reliable contraceptive methods during the study and within 90 days after the end of their participation. A reliable method of contraception is a combination of a male condom with at least one of the following methods:
hormonal contraceptives used by the male's partner (only if she does not participate in this clinical study);
use of aerosols, creams, suppositories and other agents containing spermicides;
use of intrauterine device by female partner.

Who cannot join

History of allergies, including at least one episode of allergy to medications.
Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, ENT, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, skin.
Hypolactasia (lactose intolerance, lactase deficiency) or glucose-galatose malabsorption in medical history.
Chronic eye diseases except for myopia, hypermetropia and astigmatism of mild and moderate severity.
Surgeries on the gastrointestinal tract (except for appendectomy done more than 1 year before screening).
Regular administration or use (including externally) of hormonal agent for more than 1 week less than 45 days before screening

Show all 20Show fewer

Regular administration of medicinal products less than 4 weeks before screening.
Use of medicinal products that have a pronounced effect on liver function or hemodynamics (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before screening.
Positive test for narcotics and psychotropic products.
Blood pressure after resting in supine position for at least 5 minutes above 130 mm Hg (systolic blood pressure) and 90 mm Hg (diastolic blood pressure) or below 110 mm Hg (systolic blood pressure) and 60 mm Hg (diastolic blood pressure).
Heart rate (according to ECG) after resting in supine position for at least 5 minutes above 90 bpm or below 60 bpm.
Blood donation (450 mL of blood or plasma and more) less than 3 months before the screening.
Acute infectious diseases less than 4 weeks before screening.
Administration of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine or 50 mL of a spirit) or history of alcoholism, drug abuse, substance abuse.
Mental diseases.
Smoking for three months before screening.
Participation in any clinical study less than 3 months before screening.
Planned conception or sperm donation during the study after the administration of the investigational product or within 3 months after the last administration of the product.
Positive pregnancy test for women.
Breastfeeding period.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Clinical hospital at the Yaroslavl station of the Open Joint Stock Company Russian Railways
Yaroslavl, 150030

Other trials in Russia

About this study

Official title: An Open-label, Prospective Study of Safety, Tolerability, Pharmacokinetics and Food Effects of PBTZ169, 80 mg Capsules, When Used in Ascending Doses in Healthy Volunteers

Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers

Read the detailed description

Open-label prospective non-comparativerandomized cohort study of safety, tolerability, pharmacokinetics and the effect of food of PBTZ169 in adult healthy volunteers after single and multiple oral administration. Study was conducted in one study center in the Russian Federation. The study included two stages:

Stage 1 - single or double oral administration with dose escalation (fasted/after meal) in 5 cohorts 10 healthy volunteers each plus 5 back-up volunteers;

Stage 2 - multiple oral administration once a day after meal for 14 days in 1 cohort of 10 healthy volunteers.

Conditions: Healthy Subjects
Being tested: PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD, PBTZ169 1280 mg SD, PBTZ169 1280 mg MD
Keywords: PBTZ169, Macozinone, Antimycobacterial, Tuberculosis, Drug Resistant Tubercolosis, MDR-TB, XDR-TB
Medical subject headings: Tuberculosis, Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis

What participants receive

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

PBTZ169 640 mg ODDrug
Also called Macozinone (PBTZ169)
Two administrations once a day with a wash-out period: food effect
PBTZ169 640 mg BiDDrug
Also called Macozinone (PBTZ169)
Twice a day fasted; 1 day of administration
PBTZ169 960 mg SDDrug
Also called Macozinone (PBTZ169)
Once a day fasted
PBTZ169 1280 mg SDDrug
Also called Macozinone (PBTZ169)
Once a day fasted
PBTZ169 1280 mg MDDrug
Also called Macozinone (PBTZ169)
Once a day after meal, 14 doses

Study groups in NCT04150224
Study group	Role	What they receive
Cohort 1 (C1A), PBTZ169	Experimental	Two doses of PBTZ169: 640 mg OD fasted and 640 mg OD after meal. Wash-out period ≥6 days. Receives: Drug: PBTZ169 640 mg OD
Cohort 1 (C1B), PBTZ169	Experimental	Two doses of PBTZ169: 640 mg OD after meal and 640 OD mg fasted. Wash-out period ≥6 days. Receives: Drug: PBTZ169 640 mg OD
Cohort 2 (C2), PBTZ169	Experimental	Single dose of PBTZ169: 960 mg fasted Receives: Drug: PBTZ169 960 mg SD
Cohort 3 (C3), PBTZ169	Experimental	Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg Receives: Drug: PBTZ169 640 mg BiD
Cohort 4 (C4), PBTZ169	Experimental	Single dose of PBTZ169: 1280 mg fasted Receives: Drug: PBTZ169 1280 mg SD
Cohort 5 (C5), PBTZ169	Experimental	Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days Receives: Drug: PBTZ169 1280 mg MD

What is being measured

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

Number of Adverse Events
Safety and tolerability: number of (S)AEs
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Number of Subjects With AEs
Safety and tolerability: number of subjects with adverse events
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake

Secondary outcomes (17)

CS Changes in Vital Signs
Safety and tolerability:Clinically significant changes in vital signs (blood pressure, HR, body temperature, RR)
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
ECG Results (Safety and Tolerability)
Clinically significant abnormal deviations in ECG findings
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Laboratory Examinations Results (Safety and Tolerability)
Complete blood count, biochemical blood test, urine analysis
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Results of Physical Examination: CS Deviations
Safety and tolerability: number of physical examinations with CS deviations in results
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Peak Plasma Concentration (Сmax)
Сmax of PBTZ169 at the timepoints:
C1A, C1B, C2 and C4: point 0 (-5 min to -1 min), 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 9:00, 12:00, 24:00, 48:00 and 72:00 (h:min).
C3 (two administrations): point 0 (-5 min to -1 min), 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 9:00, 12:00 (the point before the second administration from -5 min to -1 min), 12:30, 13:00, 13:30, 14:00, 15:00, 16:00, 18:00, 21:00, 24:00, 48:00 , 72:00 (h:min) after the first administration of the medicinal product.
C5 (14 days of intake): 5 minutes before the administration (only until the first dose), 0 min and within 24 h after the administration of the 1st, 7th and last (14th) dose: 0:15, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 (h:min after the administration of a dose of the medicinal product); at 48 h and 72 h points after the last (14th) dose of PBTZ169
Measured: In the dosing interval (up to 72 hours after the last drug administration)
Trough Concentration With Repeated Administration (Ctrough)
PBTZ169 concentration before drug intake (Days 2 - 15)
Measured: Up to 72 hours after the last drug administration
Time to Reach Maximum Concentration (Tmax)
Cohort 3: Tmax relative to the time of administration in any dosage interval
Measured: Up to 72 hours after the last drug administration
Plasma Half-life Time (T1/2)
Measured: Up to 72 hours after the last drug administration
Area Under the Concentration-time Curve (AUC0 t)
In the time interval from 0 to time (t) when the last blood sample is collected with a concentration above the limit of quantification.
C5: for the data of Day 14 based on measurements within 72 hours after the last dose administration
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
Area Under the Concentration-time Curve (AUC0-24)
C5 (multiple administration once a day for 14 days): AUC0-24 was calculated based on measurements within 24 hours after PBTZ169 intake
Measured: In the dosing interval (up to 24 hours after drug administration)
Total Clearance (Clt/F)
Measured: Up to 72 hours after the last drug administration
Volume of Distribution (Vd/F)
Measured: Up to 72 hours after the last drug administration
Elimination Constant Kel
Measured: Up to 72 hours after the last drug administration
Relative Bioavailability
f=AUC0-∞(T)/AUC0-∞(R); f'=AUC0-t(T)/AUC0-t(R) Test (T) - PBTZ169 640 mg after meals, reference (R) - PBTZ169 640 mg fasted
Measured: Up to 72 hours after the last drug administration
Relative Degree of Absorption
f"=Cmax(T)/Cmax(R). Test (T) - PBTZ169 640 mg after meals, reference (R) - PBTZ169 640 mg fasted
Measured: Up to 72 hours after the last drug administration
Number of Subjects With CS Changes in Vital Signs
Safety and tolerability: No. of sbjs with clinically significant changes in vital signs (blood pressure, HR, body temperature, RR)
Measured: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake

Timeline

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

3 Jul 20181 Feb 2019

First posted4 Nov 2019
Study start3 Jul 2018
Primary completion23 Nov 2018
Study completion1 Feb 2019

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 Healthy SubjectsStudies 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: Sequential
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04150224
Sponsor's protocol ID: PBTZ169-Z00-C01-3
Status last verified: Feb 2020
First submitted: 18 Oct 2019
Last updated: 28 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Prospective Study of Safety, Tolerability, Pharmacokinetics and Food Effects of PBTZ169, 80 mg Capsules, When Used in Ascending Doses in Healthy Volunteers
ClinicalTrials.gov ID: NCT04150224
Acronym / sponsor ID: PBTZ169-Z00-C01-3
Conditions: Healthy Subjects
Keywords: PBTZ169, Macozinone, Antimycobacterial, Tuberculosis, Drug Resistant Tubercolosis, MDR-TB, XDR-TB
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Nearmedic Plus LLCIndustry (pharma, biotech, devices)
Study start: 3 Jul 2018 (actual)
Primary completion: 23 Nov 2018 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 4 Nov 2019 (actual)
Results: Posted 28 Feb 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 ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers

Detailed description

Stage 1 - single or double oral administration with dose escalation (fasted/after meal) in 5 cohorts 10 healthy volunteers each plus 5 back-up volunteers;

Stage 2 - multiple oral administration once a day after meal for 14 days in 1 cohort of 10 healthy volunteers.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1 (C1A), PBTZ169	Experimental	Drug: PBTZ169 640 mg ODTwo doses of PBTZ169: 640 mg OD fasted and 640 mg OD after meal. Wash-out period ≥6 days.
Cohort 1 (C1B), PBTZ169	Experimental	Drug: PBTZ169 640 mg ODTwo doses of PBTZ169: 640 mg OD after meal and 640 OD mg fasted. Wash-out period ≥6 days.
Cohort 2 (C2), PBTZ169	Experimental	Drug: PBTZ169 960 mg SDSingle dose of PBTZ169: 960 mg fasted
Cohort 3 (C3), PBTZ169	Experimental	Drug: PBTZ169 640 mg BiDTwo doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg
Cohort 4 (C4), PBTZ169	Experimental	Drug: PBTZ169 1280 mg SDSingle dose of PBTZ169: 1280 mg fasted
Cohort 5 (C5), PBTZ169	Experimental	Drug: PBTZ169 1280 mg MDMultiple administration of PBTZ169: 1280 mg once a day after meal for 14 days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Written informed consent from the volunteer.
Men and women aged 18-45 years, inclusive.
Body mass index of 18.5-30 kg/m2.
Verified "healthy" diagnosis based on physical examination, vital signs, standard laboratory tests (complete blood count and biochemical blood test, urine analysis) and instrumental tests (ECG, fluorography examination or X-ray examination).
Negative results of tests for human immunodeficiency virus (HIV), syphilis, hepatitis B (Hbs Ag) and hepatitis C (antibodies to HCV).

Key exclusion criteria (20 listed)

History of allergies, including at least one episode of allergy to medications.
Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, ENT, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, skin.
Hypolactasia (lactose intolerance, lactase deficiency) or glucose-galatose malabsorption in medical history.
Chronic eye diseases except for myopia, hypermetropia and astigmatism of mild and moderate severity.
Surgeries on the gastrointestinal tract (except for appendectomy done more than 1 year 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 640 mg ODAlso: Macozinone (PBTZ169)Two administrations once a day with a wash-out period: food effect	Drug	Cohort 1 (C1A), PBTZ169, Cohort 1 (C1B), PBTZ169
PBTZ169 640 mg BiDAlso: Macozinone (PBTZ169)Twice a day fasted; 1 day of administration	Drug	Cohort 3 (C3), PBTZ169
PBTZ169 960 mg SDAlso: Macozinone (PBTZ169)Once a day fasted	Drug	Cohort 2 (C2), PBTZ169
PBTZ169 1280 mg SDAlso: Macozinone (PBTZ169)Once a day fasted	Drug	Cohort 4 (C4), PBTZ169
PBTZ169 1280 mg MDAlso: Macozinone (PBTZ169)Once a day after meal, 14 doses	Drug	Cohort 5 (C5), PBTZ169

Primary outcome

Number of Adverse Events
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Safety and tolerability: number of (S)AEs
Number of Subjects With AEs
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Safety and tolerability: number of subjects with adverse events

17 secondary outcomes

CS Changes in Vital Signs
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
ECG Results (Safety and Tolerability)
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Laboratory Examinations Results (Safety and Tolerability)
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Results of Physical Examination: CS Deviations
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake
Peak Plasma Concentration (Сmax)
Time frame: In the dosing interval (up to 72 hours after the last drug administration)
Trough Concentration With Repeated Administration (Ctrough)
Time frame: Up to 72 hours after the last drug administration
Time to Reach Maximum Concentration (Tmax)
Time frame: Up to 72 hours after the last drug administration
Plasma Half-life Time (T1/2)
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
Area Under the Concentration-time Curve (AUC0-∞)
Time frame: Up to 72 hours after the last drug administration
Area Under the Concentration-time Curve (AUC0-24)
Time frame: In the dosing interval (up to 24 hours after drug administration)
Total Clearance (Clt/F)
Time frame: Up to 72 hours after the last drug administration
Volume of Distribution (Vd/F)
Time frame: Up to 72 hours after the last drug administration
Elimination Constant Kel
Time frame: Up to 72 hours after the last drug administration
Relative Bioavailability
Time frame: Up to 72 hours after the last drug administration
Relative Degree of Absorption
Time frame: Up to 72 hours after the last drug administration
Number of Subjects With CS Changes in Vital Signs
Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake

Results and safety

Results posted to the registry on 28 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (C1A), PBTZ169	10	10
Cohort 1 (C1B), PBTZ169	10	10
Cohort 2 (C2), PBTZ169	10	10
Cohort 3 (C3), PBTZ169	10	10
Cohort 4 (C4), PBTZ169	10	10
Cohort 5 (C5), PBTZ169	10	10

Primary outcome: Number of Adverse Events

Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake. Number. Unit: AEs

Measure	Cohort 1 (C1A+C1B), PBTZ169 n = 20	Cohort 2 (C2), PBTZ169 n = 10	Cohort 3 (C3), PBTZ169 n = 10	Cohort 4 (C4), PBTZ169 n = 10	Cohort 5 (C5), PBTZ169 n = 10
Number of AEs	9	4	5	2	9
Number of SAEs	0	0	0	0	0
Number of drug-related AEs	9	4	5	1	6
Drug-related "Cardiac disorders" AEs	3	0	1	0	0
Drug-related "GastroInt." AEs	1	1	1	1	2
Drug-related "Investigations" AEs	4	0	2	0	0
Drug-related "Nervous syst." AEs	1	3	1	0	2
Drug-related "Metabolic" AEs	0	0	0	0	2

Population analysed: Safety population

Primary outcome: Number of Subjects With AEs

Time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake. Number. Unit: participants

Measure	Cohort 1 (C1A+C1B), PBTZ169 n = 20	Cohort 2 (C2), PBTZ169 n = 10	Cohort 3 (C3), PBTZ169 n = 10	Cohort 4 (C4), PBTZ169 n = 10	Cohort 5 (C5), PBTZ169 n = 10
Number of sbjs with AEs	6	3	5	2	6
Number of sbjs with drug-related AEs	6	3	5	1	5

Population analysed: Safety population

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Single and double dosing groups - up to 5 ± 1 days after the last PBTZ169 dose intake (Cohorts 1-4): C1A, C1B - up to Day 12 ± 1 (Day 1 - 1st dosing day) C2, C3, C4 - up to Day 6 ± 1 (Day 1 - dosing day) Multiple dosing group - up to 7 ± 1 days after the last PBTZ169 dose intake (Cohort 5): C5 - up to Day 21±1 (Day 1 - 1st dosing day). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (C1A+C1B), PBTZ169	0 of 20 (0%)	6 of 20 (30%)	0 of 20
Cohort 2 (C2), PBTZ169	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Cohort 3 (C3), PBTZ169	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Cohort 4 (C4), PBTZ169	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Cohort 5 (C5), PBTZ169	0 of 10 (0%)	5 of 10 (50%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PBTZ169 640 mg OD, PBTZ169 640 mg BiD and PBTZ169 960 mg SD in people with Healthy Subjects, run by Nearmedic Plus LLC at 1 site in Russia.

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 10 inclusion and 20 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 28 Feb 2020. 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 Russia. 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. 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 28 Feb 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?

Number of Adverse Events (time frame: Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake). The study lists 2 primary outcomes in all. 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 NCT04150224.

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 28 Feb 2020.