TuberculosisPhase 1NCT04874948
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
A Phase 1 study testing 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in people with Tuberculosis and Tuberculosis, Pulmonary, run by Michael Hoelscher at 1 site in Netherlands.
Trial summary
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy adult male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory
- What is being tested?
- 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Oct 2021to 9 Nov 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex : male
- Age : 18 years to 55 years, inclusive, at screening.
- Body mass index (BMI) : 18.0 to 29.0 kg/m2, inclusive, at screening.
- Weight : 55 to 90 kg, inclusive, at screening.
- Status : healthy subjects.
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the subject, is also acceptable.
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- All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center.
- All over-the-counter medications, vitamin preparations (especially vitamin C), other food supplements, and herbal medications (eg, St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center. An exception is made for paracetamol, which is allowed up to 48 hours prior to study drug administration.
- No vaccination within 14 days prior to study drug administration.
- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and admission to the clinical research center.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, and energy drinks), grapefruit (juice), corn (whole corn kernels and popcorn), cruciferous vegetables, and bitter oranges from 48 hours (2 days) prior to admission to the clinical research center.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- Willing and able to sign the ICF.
Who cannot join
- Participation in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc.
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), or during work within 1 year prior to drug administration.
- Irregular defecation pattern (less than once per day on average).
- Employee of PRA, Nuvisan, or the Sponsor.
- History of relevant drug and/or food allergies.
- Using tobacco products within 60 days prior to drug administration.
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- History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma-hydroxybutyric acid, tricyclic antidepressants, and alcohol) at screening or admission to the clinical research center.
- Average intake of more than 24 grams of alcohol per day.
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or HIV 1 and 2 antibodies.
- Participation in a drug study within 30 days prior to drug administration in the current study. Participation in more than 4 drug studies in the 12 months prior to drug administration in the current study.
- Donation or loss of more than 450 mL of blood within 60 days prior to drug administration. Donation or loss of more than 1.5 liters of blood in the 10 months prior to drug administration in the current study.
- Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
- Unwillingness to consume the Food and Drug Administration (FDA)-recommended high-fat breakfast.
- Unsuitable veins for infusion or blood sampling.
- Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences (PRA) - Early Development Services (EDS)
Groningen
About this study
Official title: A Single-Center, Open Label Study to Investigate the Mass Balance, Excretion Pathways and Metabolites After a Single Oral Dose of 500 MG, 3.7 MBq, [14C]BTZ-043 in Healthy Male Volunteers
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy adult male subjects
Read the detailed description
A total of 4 evaluable subjects completing all procedures are required. Six (6) subjects will be enrolled in the cohort in order to have 4 evaluable subjects.
The study will consist of a screening period (Day -21 to -2), a baseline period (Day -1), a single dose treatment on Day 1 with a minimum of 96 hours (=4 days) post dose in-house observation period (Days -1 up to afternoon Day 5), and a follow-up visit 30 days (±2 days) after the [14C]BTZ-043 dose.
Subjects will be administered a single 500 mg [14C]BTZ-043 dose as drinking suspension. Subjects will be confined to the clinical site for at least 96 hours following drug administration (ie, afternoon of Day 5). During this time, blood, feces, and urine samples for measurement of [14C]BTZ-043 and metabolites will be collected.
The subjects will be released from the clinic approximately 96 hours to 168 hours after dose administration and upon satisfactory recovery of radioactivity (at least 90%) approved by the Sponsor's scientific advisor after consulation of the Sponsor.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases, Mycobacterium Infections
- Being tested
- 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
- Keywords
- Anti-Bacterial Agents
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Lung Diseases, Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043Drug
Single oral administration of 14C-labeled radioactive 500mg BTZ-043
| Study group | Role | What they receive |
|---|---|---|
| Single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 | Experimental | 4 subjects to receive a single oral administration of 14C-labeled radioactive 500mg BTZ-043 Receives: Drug: 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates and Routes of Excretion
To determine the rates and routes of excretion of [14C]BTZ-043-related radioactivity, including mass balance of total drug-related radioactivity in urine and feces (and vomit, if applicable), following the oral administration of a single 500 mg dose of [14C]BTZ-043 in healthy male volunteers. All excreta were collected for the analysis for 14C quick or normal counts of total radioactivity (as feasible). the radioactivity measured was translated into mg eq (Radioactivity equivalent to 1 mg BTZ-043).
Measured: Urine and faeces were collected from the administration of the study medication until cumulative excretion reached 90% of total radioactivity administered. This was achieved by all subjects after 168 hours.
Pharmacokinetics of Total Radioactivity in Blood and Plasma (Cmax)
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Measured: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
Pharmacokinetics of Total Radioactivity in Blood and Plasma (AUC-t)
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Measured: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
Pharmacokinetics of Total Radioactivity in Blood (T1/2)
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Measured: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
Pharmacokinetics of Total Radioactivity in Plasma (T1/2)
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Measured: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
Plasma PK of BTZ-043 and Main Metabolites (Cmax)
To characterize the plasma PK of BTZ-043 and main metabolites by liquid chromatography-mass spectrometry (LC-MS), if applicable. BTZ-043 is metabolized in the human body. Some of the metabolites were known prior to this study like the main metabolite M2, a hydrid Meisenheimer complex or the aminometabolite M1. Metabolite M4 and M10 were known before as well, therefore, the bioanalytical methods mentioned above could be developed and validated for these metabolites.Pharmacokinetic parameters are calculated from the individual plasma level measurements.
Measured: Day 1 to Day 3
Plasma PK of BTZ-043 and Main Metabolites (AUC-last)
To characterize the plasma PK of BTZ-043 and main metabolites by liquid chromatography-mass spectrometry (LC-MS), if applicable. BTZ-043 is metabolized in the human body. Some of the metabolites were known prior to this study like the main metabolite M2, a hydrid Meisenheimer complex or the aminometabolite M1. Metabolite M4 and M10 were known before as well, therefore, the bioanalytical methods mentioned above could be developed and validated for these metabolites. Pharmacokinetic parameters are calculated from the individual plasma level measurements.
Measured: Day 1 to Day 3
Plasma PK of BTZ-043 and Main Metabolites (t1/2)
To characterize the plasma PK of BTZ-043 and main metabolites by liquid chromatography-mass spectrometry (LC-MS), if applicable. BTZ-043 is metabolized in the human body. Some of the metabolites were known prior to this study like the main metabolite M2, a hydrid Meisenheimer complex or the aminometabolite M1. Metabolite M4 and M10 were known before as well, therefore, the bioanalytical methods mentioned above could be developed and validated for these metabolites. Pharmacokinetic parameters are calculated from the individual plasma level measurements.
Measured: Day 1 to Day 3
Urine Concentrations of BTZ-043 and Main Metabolites
Urine volume was measured after every micturation and hamilton pools have been prepared for analysis of BTZ-043 and main metabolites by LC-MS. BTZ-043 could only be measured in urine within the first 24h, then no additional BTZ-043 was excreted in urine anymore. The same applies for M1. M2, M4 total and M10 total excretion could be measured in urine up to 48h post dose.
Measured: Assessed from time of dosing up to 168 h post dose. BTZ-043 and metabolites were excreted fom 0 - 24 h (BTZ-043 and M1) and from 0 - 48 h (M2, M4 total and M10 total).
Secondary outcomes (1)
Number of Adverse Events
To assess the safety and tolerability of a single 500 mg oral dose of BTZ-043 administered to healthy volunteers.
Measured: Day -1 to day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start8 Oct 2021
- Primary completion15 Oct 2021
- Study completion9 Nov 2021
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Hoelscher
- Sponsor type
- University, hospital or other
- Collaborators
- Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute
- Responsible party
- Sponsor-investigator, Michael Hoelscher, Ludwig-Maximilians - University of Munich
- Investigators
- Jan Jaap van Lier, MD, Principal investigator, PRA Health Sciences (PRA) - Early Development Services (EDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874948
- Sponsor's protocol ID
- LMU-IMPH-BTZ-043-03
- Status last verified
- Dec 2024
- First submitted
- 22 Apr 2021
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open Label Study to Investigate the Mass Balance, Excretion Pathways and Metabolites After a Single Oral Dose of 500 MG, 3.7 MBq, [14C]BTZ-043 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04874948
- Acronym / sponsor ID
- LMU-IMPH-BTZ-043-03
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases, Mycobacterium Infections
- Keywords
- Anti-Bacterial Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Michael HoelscherUniversity, hospital or other
- Collaborators
- Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy adult male subjects
Detailed description
A total of 4 evaluable subjects completing all procedures are required. Six (6) subjects will be enrolled in the cohort in order to have 4 evaluable subjects.
The study will consist of a screening period (Day -21 to -2), a baseline period (Day -1), a single dose treatment on Day 1 with a minimum of 96 hours (=4 days) post dose in-house observation period (Days -1 up to afternoon Day 5), and a follow-up visit 30 days (±2 days) after the [14C]BTZ-043 dose.
Subjects will be administered a single 500 mg [14C]BTZ-043 dose as drinking suspension. Subjects will be confined to the clinical site for at least 96 hours following drug administration (ie, afternoon of Day 5). During this time, blood, feces, and urine samples for measurement of [14C]BTZ-043 and metabolites will be collected.
The subjects will be released from the clinic approximately 96 hours to 168 hours after dose administration and upon satisfactory recovery of radioactivity (at least 90%) approved by the Sponsor's scientific advisor after consulation of the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 | Experimental | Drug: 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-0434 subjects to receive a single oral administration of 14C-labeled radioactive 500mg BTZ-043 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Sex : male
- Age : 18 years to 55 years, inclusive, at screening.
- Body mass index (BMI) : 18.0 to 29.0 kg/m2, inclusive, at screening.
- Weight : 55 to 90 kg, inclusive, at screening.
- Status : healthy subjects.
Key exclusion criteria (16 listed)
- Participation in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc.
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), or during work within 1 year prior to drug administration.
- Irregular defecation pattern (less than once per day on average).
- Employee of PRA, Nuvisan, or the Sponsor.
- History of relevant drug and/or food allergies.
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 |
|---|---|---|
| 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043Single oral administration of 14C-labeled radioactive 500mg BTZ-043 | Drug | Single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 |
Primary outcome
Rates and Routes of Excretion
Time frame: Urine and faeces were collected from the administration of the study medication until cumulative excretion reached 90% of total radioactivity administered. This was achieved by all subjects after 168 hours.
To determine the rates and routes of excretion of [14C]BTZ-043-related radioactivity, including mass balance of total drug-related radioactivity in urine and feces (and vomit, if applicable), following the oral administration of a single 500 mg dose of [14C]BTZ-043 in healthy male volunteers. All excreta were collected for the analysis for 14C quick or normal counts of total radioactivity (as feasible). the radioactivity measured was translated into mg eq (Radioactivity equivalent to 1 mg BTZ-043).
Pharmacokinetics of Total Radioactivity in Blood and Plasma (Cmax)
Time frame: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Pharmacokinetics of Total Radioactivity in Blood and Plasma (AUC-t)
Time frame: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Pharmacokinetics of Total Radioactivity in Blood (T1/2)
Time frame: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Pharmacokinetics of Total Radioactivity in Plasma (T1/2)
Time frame: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
To determine the pharmacokinetics (PK) of total radioactivity in whole blood and in plasma. Measured radioactivity was translated into ng equivalent of BTZ-043. Based on the ng eq, pharmacokinetic parameters were calculated.
Plasma PK of BTZ-043 and Main Metabolites (Cmax)
Time frame: Day 1 to Day 3
To characterize the plasma PK of BTZ-043 and main metabolites by liquid chromatography-mass spectrometry (LC-MS), if applicable. BTZ-043 is metabolized in the human body. Some of the metabolites were known prior to this study like the main metabolite M2, a hydrid Meisenheimer complex or the aminometabolite M1. Metabolite M4 and M10 were known before as well, therefore, the bioanalytical methods mentioned above could be developed and validated for these metabolites.Pharmacokinetic parameters are calculated from the individual plasma level measurements.
Plasma PK of BTZ-043 and Main Metabolites (AUC-last)
Time frame: Day 1 to Day 3
To characterize the plasma PK of BTZ-043 and main metabolites by liquid chromatography-mass spectrometry (LC-MS), if applicable. BTZ-043 is metabolized in the human body. Some of the metabolites were known prior to this study like the main metabolite M2, a hydrid Meisenheimer complex or the aminometabolite M1. Metabolite M4 and M10 were known before as well, therefore, the bioanalytical methods mentioned above could be developed and validated for these metabolites. Pharmacokinetic parameters are calculated from the individual plasma level measurements.
Plasma PK of BTZ-043 and Main Metabolites (t1/2)
Time frame: Day 1 to Day 3
To characterize the plasma PK of BTZ-043 and main metabolites by liquid chromatography-mass spectrometry (LC-MS), if applicable. BTZ-043 is metabolized in the human body. Some of the metabolites were known prior to this study like the main metabolite M2, a hydrid Meisenheimer complex or the aminometabolite M1. Metabolite M4 and M10 were known before as well, therefore, the bioanalytical methods mentioned above could be developed and validated for these metabolites. Pharmacokinetic parameters are calculated from the individual plasma level measurements.
Urine Concentrations of BTZ-043 and Main Metabolites
Time frame: Assessed from time of dosing up to 168 h post dose. BTZ-043 and metabolites were excreted fom 0 - 24 h (BTZ-043 and M1) and from 0 - 48 h (M2, M4 total and M10 total).
Urine volume was measured after every micturation and hamilton pools have been prepared for analysis of BTZ-043 and main metabolites by LC-MS. BTZ-043 could only be measured in urine within the first 24h, then no additional BTZ-043 was excreted in urine anymore. The same applies for M1. M2, M4 total and M10 total excretion could be measured in urine up to 48h post dose.
1 secondary outcome
Number of Adverse Events
Time frame: Day -1 to day 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- 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.
Jan Jaap van Lier, MD principal investigator
PRA Health Sciences (PRA) - Early Development Services (EDS)
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 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in people with Tuberculosis and Tuberculosis, Pulmonary, run by Michael Hoelscher at 1 site in Netherlands.
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 31 Dec 2024. 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 Netherlands. 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 5 Dec 2024). 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?
Rates and Routes of Excretion (time frame: Urine and faeces were collected from the administration of the study medication until cumulative excretion reached 90% of total radioactivity administered. This was achieved by all subjects after 168 hours.). The study lists 9 primary outcomes in all. 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 31 Dec 2024.