Soil-transmitted Helminth InfectionPhase 1NCT06412926
A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants
A Phase 1 study testing BAY 44-4400 in people with Soil-transmitted Helminth Infection and Onchocerciasis (River Blindness), run by Bayer at 1 site in Germany.
Trial summary
Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly. Common symptoms include severe itching, skin problems, and eye problems including permanent blindness. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Soil-transmitted Helminth Infection, Onchocerciasis (River Blindness)
- What is being tested?
- BAY 44-4400
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 7 May 2024to 27 Aug 2024
- 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
- Men aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening
- Women that are not breastfeeding and are of non-childbearing potential aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening
- Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, vital signs, and laboratory tests.
- Ability to understand and follow study-related instructions.
Who cannot join
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study
- History of relevant eye or vision disorders (except myopia and hyperopia).
- History of diabetes mellitus or abnormalities in glucose homeostasis.
- Surgery, medical condition, or diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal
- Febrile illness within 2 weeks before the start of the first study intervention.
- Regular use of prescription drugs, over-the-counter drugs, supplements or herbal products.
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- Use of any systemic or topical medicines or substances within 2 weeks or 5 half-lives (whichever is longer) before the start of the first administration until follow-up, in particular, use of CYP3A4 inducers (including St John's Wort) or inhibitors.
- Clinically relevant findings in the physical examination and vital signs (systolic blood pressure below 90 or above 140 mmHg, diastolic blood pressure below 60 or above 90 mmHg, pulse rate below 50 or above 90 beats per minute, as measured at screening).
- Clinically relevant deviations of safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges at screening.
- Suspicion of drug or alcohol abuse.
- Lack of compliance with study restrictions.
- Any vaccination received or planned during the period between 15 days before the first administration of study intervention and the last study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Crossover Treatment, Phase 1, Open-label, Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Single Doses of 2 Formulations of Emodepside (BAY 44-4400), and to Assess the Effect of Food in Healthy Male and Female Participants.
Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly. Common symptoms include severe itching, skin problems, and eye problems including permanent blindness.
Soil-transmitted helminthiasis is an infection caused by various parasitic worms, such as whipworm, hookworm, and roundworm in the intestines. The infection spreads through eggs found in the feces of infected people. This contaminates the soil in areas with poor sanitation. Common symptoms include stomach pain, loose stools, loss of blood and proteins, delayed development in children, and reduced work performance in adults.
Read more
Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis. Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women. It works by activating a protein called 'SLO-1', which causes paralysis and death of the parasitic worms.
The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet, as a single dose. Researchers also want to find the effect of food on the absorption of the new emodepside tablet.
The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food.
The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food. The number of participants who experience medical problems during this study will be documented.
During this study, participants will receive 2 different types of emodepside tablets. These include the newly developed tablet and an existing tablet that has already been used in other clinical studies.
At the start of the study, the researchers will ask participants about their medical and surgical history. They will also perform a health check-up for all participants, and pregnancy tests for women.
During the study, participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood.
The study doctors will confirm that the participants can take part in the study. This may take up to 21 days.
This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each.
On Day 1 of each period, participants will receive the treatments, but the order of the treatment will be different.
- Periods 1 and 2: Each participant will receive a single oral dose of the new or the existing emodepside tablet without food.
After Period 2, an initial analysis will be performed. This analysis will help decide the doses for the next periods.
- Period 3: Participants will receive a selected dose of the new emodepside tablet either with or without food.
- Period 4 (optional): If needed, participants may receive a selected dose of the new emodepside tablet either with or without food. The decisions to conduct Period 4 will depend on the results of the initial analysis.
Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period (either Period 3 or 4).
Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up.
This study will include participants who are healthy and will gain no benefit from taking emodepside. However, the results of the study will provide useful information to support the further development of the new emodepside tablet. The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside. Participants will be closely monitored by the study doctors for any medical problems.
- Being tested
- BAY 44-4400
- Keywords
- Soil-transmitted helminth infection; Onchocerciasis (river blindness)
- Medical subject headings
- Onchocerciasis, Onchocerciasis, Ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 44-4400Drug
Also called Formulation A
Film-coated tablet, oral use
BAY 44-4400Drug
Also called Formulation B
Film-coated tablet, oral use
| Study group | Role | What they receive |
|---|---|---|
| Period 1 Formulation A, fasted | Experimental | All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. Receives: Drug: BAY 44-4400 |
| Period 1 Formulation B, fasted | Experimental | All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. Receives: Drug: BAY 44-4400 |
| Period 2 - Crossover Formulation A, fasted | Experimental | All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state Receives: Drug: BAY 44-4400 |
| Period 2 - Crossover Formulation B fasted | Experimental | All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state Receives: Drug: BAY 44-4400 |
| Period 3 - no dose adjustment after Period 2 | Experimental | If no dose adjustment was needed after Period 2, all subjects will receive Formulation B in fed state Receives: Drug: BAY 44-4400 |
| Period 3 - dose adjustment after Period 2, fasted | Experimental | If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state Receives: Drug: BAY 44-4400 |
| Period 3- dose adjustment after Period 2, fed | Experimental | If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state Receives: Drug: BAY 44-4400 |
| Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fasted | Experimental | All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 Receives: Drug: BAY 44-4400 |
| Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fed | Experimental | All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 Receives: Drug: BAY 44-4400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) (0-72 hrs)
- To investigate the pharmacokinetics (PK) including
- relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A
- food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax > 5%, corrected Cmax parameters accounting for carry-over will be calculated for all participants in addition.
Measured: 0-72 hrs post dose (per period)
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) (0-72 hrs)
- To investigate the pharmacokinetics (PK) including - relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A
- food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax > 5%, corrected AUC parameters accounting for carry-over will be calculated for all participants in addition.
Measured: 0-72 hrs post dose (per period)
Secondary outcomes (1)
Number of participants who experienced treatment-emergent adverse events (TEAEs)
To investigate and evaluate the safety and tolerability of single oral doses of emodepside formulations in healthy participants.
Measured: After first administration of study intervention through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start7 May 2024
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soil-transmitted Helminth InfectionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- The study will be conducted in a single-center, randomized, open label, cross over design. The study will investigate the relative bioavailability, pharmacokinetics, safety and tolerability of single doses of 2 formulations of emodepside and assess the effect of food on Test formulation (Formulation B) in healthy male participants and healthy female participants of non-childbearing potential. The crossover design is used for intra-individual comparison of treatment effects to reduce impact of inter-individual variability. A preliminary PK analysis is planned after Period 2 to determine the appropriate dose to be tested for food effect. Treatment allocation is conducted in a randomized manner prior to Period 1 in order to reduce the likelihood of period or seasonal effects confounding the study assessments.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412926
- Sponsor's protocol ID
- 22534
- Other IDs
- 2023-508905-26-00, 2023
- Status last verified
- Sep 2024
- First submitted
- 2 May 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Treatment, Phase 1, Open-label, Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Single Doses of 2 Formulations of Emodepside (BAY 44-4400), and to Assess the Effect of Food in Healthy Male and Female Participants.
- ClinicalTrials.gov ID
- NCT06412926
- Acronym / sponsor ID
- 22534
- Keywords
- Soil-transmitted helminth infection; Onchocerciasis (river blindness)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 14 May 2024 (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.
Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly. Common symptoms include severe itching, skin problems, and eye problems including permanent blindness.
Soil-transmitted helminthiasis is an infection caused by various parasitic worms, such as whipworm, hookworm, and roundworm in the intestines. The infection spreads through eggs found in the feces of infected people. This contaminates the soil in areas with poor sanitation. Common symptoms include stomach pain, loose stools, loss of blood and proteins, delayed development in children, and reduced work performance in adults.
Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis. Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women. It works by activating a protein called 'SLO-1', which causes paralysis and death of the parasitic worms.
The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet, as a single dose. Researchers also want to find the effect of food on the absorption of the new emodepside tablet.
The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food.
The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food. The number of participants who experience medical problems during this study will be documented.
During this study, participants will receive 2 different types of emodepside tablets. These include the newly developed tablet and an existing tablet that has already been used in other clinical studies.
At the start of the study, the researchers will ask participants about their medical and surgical history. They will also perform a health check-up for all participants, and pregnancy tests for women.
During the study, participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood.
The study doctors will confirm that the participants can take part in the study. This may take up to 21 days.
This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each.
On Day 1 of each period, participants will receive the treatments, but the order of the treatment will be different.
- Periods 1 and 2: Each participant will receive a single oral dose of the new or the existing emodepside tablet without food.
After Period 2, an initial analysis will be performed. This analysis will help decide the doses for the next periods.
- Period 3: Participants will receive a selected dose of the new emodepside tablet either with or without food.
- Period 4 (optional): If needed, participants may receive a selected dose of the new emodepside tablet either with or without food. The decisions to conduct Period 4 will depend on the results of the initial analysis.
Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period (either Period 3 or 4).
Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up.
This study will include participants who are healthy and will gain no benefit from taking emodepside. However, the results of the study will provide useful information to support the further development of the new emodepside tablet. The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside. Participants will be closely monitored by the study doctors for any medical problems.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- The study will be conducted in a single-center, randomized, open label, cross over design. The study will investigate the relative bioavailability, pharmacokinetics, safety and tolerability of single doses of 2 formulations of emodepside and assess the effect of food on Test formulation (Formulation B) in healthy male participants and healthy female participants of non-childbearing potential. The crossover design is used for intra-individual comparison of treatment effects to reduce impact of inter-individual variability. A preliminary PK analysis is planned after Period 2 to determine the appropriate dose to be tested for food effect. Treatment allocation is conducted in a randomized manner prior to Period 1 in order to reduce the likelihood of period or seasonal effects confounding the study assessments.
| Arm | Type | Receives |
|---|---|---|
| Period 1 Formulation A, fasted | Experimental | Drug: BAY 44-4400All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. |
| Period 1 Formulation B, fasted | Experimental | Drug: BAY 44-4400All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. |
| Period 2 - Crossover Formulation A, fasted | Experimental | Drug: BAY 44-4400All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state |
| Period 2 - Crossover Formulation B fasted | Experimental | Drug: BAY 44-4400All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state |
| Period 3 - no dose adjustment after Period 2 | Experimental | Drug: BAY 44-4400If no dose adjustment was needed after Period 2, all subjects will receive Formulation B in fed state |
| Period 3 - dose adjustment after Period 2, fasted | Experimental | Drug: BAY 44-4400If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state |
| Period 3- dose adjustment after Period 2, fed | Experimental | Drug: BAY 44-4400If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state |
| Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fasted | Experimental | Drug: BAY 44-4400All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 |
| Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fed | Experimental | Drug: BAY 44-4400All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening
- Women that are not breastfeeding and are of non-childbearing potential aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening
- Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, vital signs, and laboratory tests.
- Ability to understand and follow study-related instructions.
Key exclusion criteria (12 listed)
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study
- History of relevant eye or vision disorders (except myopia and hyperopia).
- History of diabetes mellitus or abnormalities in glucose homeostasis.
- Surgery, medical condition, or diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal
- Febrile illness within 2 weeks before the start of the first study intervention.
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 |
|---|---|---|
| BAY 44-4400Also: Formulation AFilm-coated tablet, oral use | Drug | Period 1 Formulation A, fasted, Period 2 - Crossover Formulation A, fasted |
| BAY 44-4400Also: Formulation BFilm-coated tablet, oral use | Drug | Period 1 Formulation B, fasted, Period 2 - Crossover Formulation B fasted, Period 3 - dose adjustment after Period 2, fasted, Period 3 - no dose adjustment after Period 2, Period 3- dose adjustment after Period 2, fed, Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fasted, Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fed |
Primary outcome
Maximum observed concentration (Cmax) (0-72 hrs)
Time frame: 0-72 hrs post dose (per period)
• To investigate the pharmacokinetics (PK) including * relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A * food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax > 5%, corrected Cmax parameters accounting for carry-over will be calculated for all participants in addition.
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) (0-72 hrs)
Time frame: 0-72 hrs post dose (per period)
• To investigate the pharmacokinetics (PK) including - relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A - food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax > 5%, corrected AUC parameters accounting for carry-over will be calculated for all participants in addition.
1 secondary outcome
Number of participants who experienced treatment-emergent adverse events (TEAEs)
Time frame: After first administration of study intervention through study completion, an average of 12 weeks
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 27 Sep 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 BAY 44-4400 in people with Soil-transmitted Helminth Infection and Onchocerciasis (River Blindness), run by Bayer 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 4 inclusion and 12 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 27 Sep 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 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. 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?
Maximum observed concentration (Cmax) (0-72 hrs) (time frame: 0-72 hrs post dose (per period)). 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?
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 27 Sep 2024.