TuberculosisPhase 1NCT03590600

A Single Ascending Dose Study of BTZ043

A Phase 1 study testing BTZ-043 in people with Tuberculosis and Tuberculosis, Pulmonary, run by Michael Hoelscher at 1 site in Germany.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections
What is being tested?: BTZ-043
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteGermany
Study dates: 7 Jun 2018to 5 Mar 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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provide written informed consent
Healthy male or female subjects aged between ≥18 and ≤55 years at screening who are able to read, write, and fully understand the German language
BMI between ≥18 and ≤30 kg/m2, with a body weight between ≥55 and ≤90 kg at screening
Vital signs within range: pulse rate 50-90 bpm, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mmHg
No clinically significant findings in laboratory tests
Women must be of non-childbearing potential, that is, either postmenopausal or premenopausal with documented tubal ligation or hysterectomy or women who are at least 6 weeks post-surgical bilateral oophorectomy

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Male subjects must agree to use a condom with spermicide when engaging in sexual intercourse during the study period and for 2 months after study drug dosing, if they have not had a vasectomy at least 6 months before study start
Male subjects must not donate sperm during the study and for 2 months after study drug dosing
Able to swallow the amount of drug in succession
Agree not to donate blood (or bloodcomponents) until 1 month after receiving study drug
Normal consumption of alcohol
Willing to forgo sunbathing and prolonged exposure to sunlight during the study period
Willing to forgo strenuous exercise from 72 hours prior to admission until discharge

Who cannot join

Any known chronic systemic viral infection
Any relevant systemic infection or other systemic illness
Vaccination 30 days prior to drug administration
Known hypersensitivity to any of the excipients of the study drug
A clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history or any other medical condition
History of or current alcohol or illicit drug abuse

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Positive results in the urine drug screen or blood alcohol test at admission
Current or recent (within the past 3 months before drug administration) use of tobacco or other nicotine-containing product or positive results of cotinine test at screening or admission
Use of any prescription or over-the-counter (OTC) drug or herbal product within 14 days before drug administration with exception for sporadic use of ibuprofen or paracetamol for example in case of pain
Use of any known drug metabolism enzyme-altering drug or supplement within 14 days before dosing or consumption of foods or beverages containing grapefruit within 48 hours before admission
ECG findings in the screening ECG of QTcF-interval over 450 ms; atrioventricular (AV) block with PR-interval over 200 ms, prolongation of the QRS complex over 120 ms, or other changes in the ECG that are clinically relevant as per discretion of the investigator
Long QT syndrome, or family history of long QT syndrome or sudden death of unknown or cardiac-related cause
Use or planned necessary use of any QT-prolonging agents
Participation in another investigational drug study within the previous 30 days before drug administration
Any donation of blood, plasma, or platelets or significant loss of blood within the previous 30 days before drug administration
Previous randomization in this study
Volunteer unwilling or unable to comply with protocol requirements in the judgment of the investigator
Vulnerable subject (e.g. person is kept in detention)
Employees of the sponsor or subjects who are employees or relatives of the investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

Nuvisan
Neu-Ulm, Bavaria, 89231

Other trials in Germany

About this study

Official title: A Randomized, Double Blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Doses of BTZ043 in Healthy Adult Volunteers

This study is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics of single doses of BTZ043 in healthy adult volunteers. The study is conducted at a study centre in Germany. Up to 50 male and female participants will be included in this study in up to 5 cohorts; each cohort will consist of 10 subjects: in each cohort 8 subjects will be assigned to BTZ-043 and 2 to placebo. The doses tested will be: 125mg, 250mg, 500mg, 1000mg and 2000mg. Safety will be assessed via regular vital sign measurement, 12-lead ECG parameters, physical examination and safety laboratory assessments.

Subjects will be hospitalized from Day -1 until discharge in the morning of Day 3. After completion of all Day 3 assessments of a cohort, blinded safety data will be reviewed and the next dose increment will be decided by the Trial Steering Committee (TSC).

Conditions: Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections, Lung Diseases, Mycobacterium Infections
Being tested: BTZ-043, Placebo
Keywords: Phase 1, Anti-Bacterial Agents, Respiratory Tract Infections
Medical subject headings: Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections, Lung Diseases, Mycobacterium Infections, Respiratory Tract Infections

What participants receive

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

BTZ-043Drug
Powder and solvent for oral suspension
PlaceboDrug
Matching placebo: powder and solvent for oral suspension

Study groups in NCT03590600
Study group	Role	What they receive
Cohort 1: 125 mg BTZ-043 fasting	Experimental	N=8, 125 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose Receives: Drug: BTZ-043
Cohort 1: Placebo	Placebo comparator	N=2, matching placebo, powder and solvent for oral solution, single dose Receives: Drug: Placebo
Cohort 2: 250 mg BTZ-043 fasting	Experimental	N=8, 250 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose Receives: Drug: BTZ-043
Cohort 2: Placebo	Placebo comparator	N=2, matching placebo, powder and solvent for oral solution, single dose Receives: Drug: Placebo
Cohort 3: 500 mg BTZ-043 fasting	Experimental	N=8, 500 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose Receives: Drug: BTZ-043
Cohort 3: Placebo	Placebo comparator	N=2, matching placebo, powder and solvent for oral solution, single dose Receives: Drug: Placebo
Cohort 4: 1000 mg BTZ-043 fasting	Experimental	N=8, 1000 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose Receives: Drug: BTZ-043
Cohort 4: Placebo	Placebo comparator	N=2, matching placebo, powder and solvent for oral solution, single dose Receives: Drug: Placebo
Cohort 5: 2000mg BTZ-043 fasting	Experimental	N=8, 2000 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose Receives: Drug: BTZ-043
Cohort 5: Placebo	Placebo comparator	N=2, matching placebo, powder and solvent for oral solution, single dose Receives: Drug: Placebo

What is being measured

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

Number of participants with treatment-related adverse events concerning ECG as assessed by CTCAE v4.03 (Common Terminology Criteria for Adverse Events)
Measured by 12-lead ECG assessments on 6 different timepoints.
Measured: 0.5 hours to 12.0 hours post-dosing
Number of participants with treatment-related adverse events concerning safety laboratory as assessed by CTCAE v4.03
Measured by clinical chemistry, haematology, coagulation, urinalysis on 2 different timepoints
Measured: 24 hours to 26 hours post-dosing
Number of participants with treatment-related adverse events concerning vital signs as assessed by CTCAE v4.03
Measured by blood pressure, pulse rate, respiratory rate and tympanic body temperature on 7 different timepoints
Measured: 0.25 hours to 48 hours post-dosing
Number of participants with treatment-related adverse events concerning clinical observations as assessed by CTCAE v4.03
Examination of general appearance, skin, neck (including thyroid), throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological systems.
Measured: 4 hours to 48 hours post-dosing

Secondary outcomes (3)

Pharmacokinetic assessment of BTZ-043 after a single oral dose
Blood samples for the determination of Area under the plasma concentration versus time curve (AUC) will be assessed in BTZ-043 and the metabolites BTZ-045S and M2
Measured: 0.25 hours to 36 hours post-dosing
Pharmacokinetic assessment of BTZ-043 after a single oral dose
Blood samples for the determination of Peak Plasma Concentration (Cmax) will be assessed in BTZ-043 and the metabolites BTZ-045S and M2
Measured: 0.25 hours to 36 hours post-dosing
Determining the effect of sex differences on systemic exposure by analyzing the PK of BTZ-043 in male and female participants.
Estimated via comparison of the exposure (AUC0-inf) of BTZ-043 in males and females
Measured: 0.25 hours to 36 hours post-dosing

Timeline

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

7 Jun 20185 Mar 2019

First posted18 Jul 2018
Study start7 Jun 2018
Primary completion14 Aug 2018
Study completion5 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03590600
Sponsor's protocol ID: LMU-IMPH-BTZ043-01
Status last verified: Mar 2019
First submitted: 4 Jun 2018
Last updated: 7 Mar 2019
Results posted: No
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Doses of BTZ043 in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT03590600
Acronym / sponsor ID: LMU-IMPH-BTZ043-01
Conditions: Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections, Lung Diseases, Mycobacterium Infections
Keywords: Phase 1, Anti-Bacterial Agents, Respiratory Tract Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Michael HoelscherUniversity, hospital or other
Collaborators: German Center for Infection Research, German Federal Ministry of Education and Research, Hans Knöll Institute (HKI)
Study start: 7 Jun 2018 (actual)
Primary completion: 14 Aug 2018 (actual)
Study completion: 5 Mar 2019 (actual)
First posted: 18 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Cohort 1: 125 mg BTZ-043 fasting	Experimental	Drug: BTZ-043N=8, 125 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose
Cohort 1: Placebo	Placebo comparator	Drug: PlaceboN=2, matching placebo, powder and solvent for oral solution, single dose
Cohort 2: 250 mg BTZ-043 fasting	Experimental	Drug: BTZ-043N=8, 250 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose
Cohort 2: Placebo	Placebo comparator	Drug: PlaceboN=2, matching placebo, powder and solvent for oral solution, single dose
Cohort 3: 500 mg BTZ-043 fasting	Experimental	Drug: BTZ-043N=8, 500 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose
Cohort 3: Placebo	Placebo comparator	Drug: PlaceboN=2, matching placebo, powder and solvent for oral solution, single dose
Cohort 4: 1000 mg BTZ-043 fasting	Experimental	Drug: BTZ-043N=8, 1000 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose
Cohort 4: Placebo	Placebo comparator	Drug: PlaceboN=2, matching placebo, powder and solvent for oral solution, single dose
Cohort 5: 2000mg BTZ-043 fasting	Experimental	Drug: BTZ-043N=8, 2000 mg BTZ-043 fasting, oral administration, powder and solvent for oral suspension, single dose
Cohort 5: Placebo	Placebo comparator	Drug: PlaceboN=2, matching placebo, powder and solvent for oral solution, single dose

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Provide written informed consent
Healthy male or female subjects aged between ≥18 and ≤55 years at screening who are able to read, write, and fully understand the German language
BMI between ≥18 and ≤30 kg/m2, with a body weight between ≥55 and ≤90 kg at screening
Vital signs within range: pulse rate 50-90 bpm, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mmHg
No clinically significant findings in laboratory tests

Key exclusion criteria (19 listed)

Any known chronic systemic viral infection
Any relevant systemic infection or other systemic illness
Vaccination 30 days prior to drug administration
Known hypersensitivity to any of the excipients of the study drug
A clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history or any other medical condition

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
BTZ-043Powder and solvent for oral suspension	Drug	Cohort 1: 125 mg BTZ-043 fasting, Cohort 2: 250 mg BTZ-043 fasting, Cohort 3: 500 mg BTZ-043 fasting, Cohort 4: 1000 mg BTZ-043 fasting, Cohort 5: 2000mg BTZ-043 fasting
PlaceboMatching placebo: powder and solvent for oral suspension	Drug	Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo, Cohort 5: Placebo

Primary outcome

Number of participants with treatment-related adverse events concerning ECG as assessed by CTCAE v4.03 (Common Terminology Criteria for Adverse Events)
Time frame: 0.5 hours to 12.0 hours post-dosing
Measured by 12-lead ECG assessments on 6 different timepoints.
Number of participants with treatment-related adverse events concerning safety laboratory as assessed by CTCAE v4.03
Time frame: 24 hours to 26 hours post-dosing
Measured by clinical chemistry, haematology, coagulation, urinalysis on 2 different timepoints
Number of participants with treatment-related adverse events concerning vital signs as assessed by CTCAE v4.03
Time frame: 0.25 hours to 48 hours post-dosing
Measured by blood pressure, pulse rate, respiratory rate and tympanic body temperature on 7 different timepoints
Number of participants with treatment-related adverse events concerning clinical observations as assessed by CTCAE v4.03
Time frame: 4 hours to 48 hours post-dosing
Examination of general appearance, skin, neck (including thyroid), throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological systems.

3 secondary outcomes

Pharmacokinetic assessment of BTZ-043 after a single oral dose
Time frame: 0.25 hours to 36 hours post-dosing
Pharmacokinetic assessment of BTZ-043 after a single oral dose
Time frame: 0.25 hours to 36 hours post-dosing
Determining the effect of sex differences on systemic exposure by analyzing the PK of BTZ-043 in male and female participants.
Time frame: 0.25 hours to 36 hours post-dosing

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.

Related trials for Tuberculosis

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RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
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A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
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Active, not recruitingObservational study
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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 BTZ-043 in people with Tuberculosis and Tuberculosis, Pulmonary, run by Michael Hoelscher at 1 site in Germany.

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 19 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 7 Mar 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 Germany. 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?

Number of participants with treatment-related adverse events concerning ECG as assessed by CTCAE v4.03 (Common Terminology Criteria for Adverse Events) (time frame: 0.5 hours to 12.0 hours post-dosing). The study lists 4 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 NCT03590600.

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 7 Mar 2019.