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CompletedNCT03282929Updated Jun 21, 2019

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 interventional study of Part 1 and Part 2 Group 1 in Anaphylaxis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in Germany. Open to participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.

Sponsored by Bausch & Lomb Incorporated · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 54 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Anaphylaxis

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03

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male and female subjects, between 18 and 54 years of age (inclusive).
  2. Subjects who are able and willing to give written informed consent.
  3. 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.
  4. Compressed STMD of 10 mm and above (Part 1+2).
  5. Non-smoker for at least 6 months.

Exclusion criteria

Exclusion Criteria:

  1. Receipt of medication (prescription or non-prescription) within 14 days prior to the planned drug administration, except for occasional use of paracetamol or ibuprofen.
  2. 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.
  3. 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.

  4. Presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  5. Hypersensitivity to epinephrine or any of the excipients (e.g. metabisulphite).
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Part 1 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.

    Device: Part 1

  • Experimental
    Part 2 group 1

    300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

    Device: Part 2 Group 1

  • Experimental
    Part 2 Group 2

    500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

    Drug: Part 2 group 2

  • Experimental
    Part 2 Group 3

    300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)

    Device: Part 2 group 3

  • Experimental
    Part 2 Group 4

    300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)

    Device: Part 2 Group 4

Interventions

  • DevicePart 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

    Also known as: Group 1

  • DevicePart 2 Group 1

    300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

    Also known as: Group 1

  • DrugPart 2 group 2

    500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

    Also known as: Group 2

  • DevicePart 2 group 3

    300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)

    Also known as: Group 3

  • DevicePart 2 Group 4

    300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)

    Also known as: Group 4

05

What researchers measure

Primary outcomes

  1. Cmax

    Maximum observed drug concentration

    Time frame: 14 days

  2. 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.

    Time frame: 14 days

06

Study locations

1 site
  • Nuvisan GmbH
    Neu-Ulm, Wegenerstrasse 13 89231, Germany
07

Registry details

Key details

Study ID
NCT03282929
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Mar 23, 2017
Primary completion
Sep 28, 2018
Completion
Oct 15, 2018
Last update
Jun 21, 2019

Study contacts

Beate Klaus, MD
principal investigator · Baush and Lomb

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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