AnaphylaxisPhase 1NCT03282929
Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
A Phase 1 study testing Part 1, Part 2 Group 1 and Part 2 group 2 in people with Anaphylaxis, run by Bausch & Lomb Incorporated at 1 site in Germany.
Trial summary
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis
- What is being tested?
- Part 1, Part 2 Group 1 and Part 2 group 2
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2017to 15 Oct 2018
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, between 18 and 54 years of age (inclusive).
- Subjects who are able and willing to give written informed consent.
- Body mass index (BMI) between 28.0 and 40.0 kg/m² (inclusive). Weight on Day -1 may not have changed by more than 3 kg compared to screening.
- Compressed STMD of 10 mm and above (Part 1+2).
- Non-smoker for at least 6 months.
Who cannot join
- Receipt of medication (prescription or non-prescription) within 14 days prior to the planned drug administration, except for occasional use of paracetamol or ibuprofen.
- Receipt of any of the following medications within the previous 6 months; beta adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors and catechol-O-methyl transferase inhibitors, methylphenidate, amphetamines, any drugs that may sensitize the heart to arrhythmias, including digitalis and quinidine.
- History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study.
- History or presence of silent infections, including positive tests for HIV1, HIV2, Hepatitis B or C.
- Presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Hypersensitivity to epinephrine or any of the excipients (e.g. metabisulphite).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Single-dose, Open Label, Randomized Cross-over Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
Read the detailed description
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
- Conditions
- Anaphylaxis
- Being tested
- Part 1, Part 2 Group 1, Part 2 group 2, Part 2 group 3, Part 2 Group 4
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1Device
Also called Group 1
A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order
Part 2 Group 1Device
Also called Group 1
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Part 2 group 2Drug
Also called Group 2
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Part 2 group 3Device
Also called Group 3
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
Part 2 Group 4Device
Also called Group 4
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Group 1 | Experimental | A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order. Receives: Device: Part 1 |
| Part 2 group 1 | Experimental | 300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) Receives: Device: Part 2 Group 1 |
| Part 2 Group 2 | Experimental | 500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) Receives: Drug: Part 2 group 2 |
| Part 2 Group 3 | Experimental | 300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length) Receives: Device: Part 2 group 3 |
| Part 2 Group 4 | Experimental | 300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length) Receives: Device: Part 2 Group 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed drug concentration
Measured: 14 days
tmax
Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start23 Mar 2017
- Primary completion28 Sep 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies 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
- Crossover
- Model description
- Pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Klaus, MD, Principal investigator, Baush and Lomb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282929
- Sponsor's protocol ID
- N-A-PH1-15-050
- Status last verified
- Jun 2019
- First submitted
- 21 Jul 2017
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Single-dose, Open Label, Randomized Cross-over Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
- ClinicalTrials.gov ID
- NCT03282929
- Acronym / sponsor ID
- N-A-PH1-15-050
- Conditions
- Anaphylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 14 Sep 2017 (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.
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
Detailed description
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
| Arm | Type | Receives |
|---|---|---|
| Part 1 Group 1 | Experimental | Device: Part 1A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order. |
| Part 2 group 1 | Experimental | Device: Part 2 Group 1300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) |
| Part 2 Group 2 | Experimental | Drug: Part 2 group 2500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) |
| Part 2 Group 3 | Experimental | Device: Part 2 group 3300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length) |
| Part 2 Group 4 | Experimental | Device: Part 2 Group 4300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length) |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects, between 18 and 54 years of age (inclusive).
- Subjects who are able and willing to give written informed consent.
- Body mass index (BMI) between 28.0 and 40.0 kg/m² (inclusive). Weight on Day -1 may not have changed by more than 3 kg compared to screening.
- Compressed STMD of 10 mm and above (Part 1+2).
- Non-smoker for at least 6 months.
Key exclusion criteria (6 listed)
- Receipt of medication (prescription or non-prescription) within 14 days prior to the planned drug administration, except for occasional use of paracetamol or ibuprofen.
- Receipt of any of the following medications within the previous 6 months; beta adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors and catechol-O-methyl transferase inhibitors, methylphenidate, amphetamines, any drugs that may sensitize the heart to arrhythmias, including digitalis and quinidine.
- History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study.
- History or presence of silent infections, including positive tests for HIV1, HIV2, Hepatitis B or C.
- Presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
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 |
|---|---|---|
| Part 1Also: Group 1A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order | Device | Part 1 Group 1 |
| Part 2 Group 1Also: Group 1300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) | Device | Part 2 group 1 |
| Part 2 group 2Also: Group 2500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) | Drug | Part 2 Group 2 |
| Part 2 group 3Also: Group 3300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length) | Device | Part 2 Group 3 |
| Part 2 Group 4Also: Group 4300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length) | Device | Part 2 Group 4 |
Primary outcome
Cmax
Time frame: 14 days
Maximum observed drug concentration
tmax
Time frame: 14 days
Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
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 21 Jun 2019.
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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.
Beate Klaus, MD principal investigator
Baush and Lomb
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 Part 1, Part 2 Group 1 and Part 2 group 2 in people with Anaphylaxis, run by Bausch & Lomb Incorporated 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 5 inclusion and 6 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 21 Jun 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. 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?
Cmax (time frame: 14 days). 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 21 Jun 2019.