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Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)

Primary Purpose

Anaphylaxis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Part 1
Part 2 Group 1
Part 2 group 2
Part 2 group 3
Part 2 Group 4
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaphylaxis

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  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).

Sites / Locations

  • Nuvisan GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1 Group 1

Part 2 group 1

Part 2 Group 2

Part 2 Group 3

Part 2 Group 4

Arm Description

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.

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

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

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

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

Outcomes

Primary Outcome Measures

Cmax
Maximum observed drug concentration
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.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2017
Last Updated
June 20, 2019
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03282929
Brief Title
Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaphylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 group 1
Arm Type
Experimental
Arm Description
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Arm Title
Part 2 Group 2
Arm Type
Experimental
Arm Description
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Arm Title
Part 2 Group 3
Arm Type
Experimental
Arm Description
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
Arm Title
Part 2 Group 4
Arm Type
Experimental
Arm Description
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
Intervention Type
Device
Intervention Name(s)
Part 1
Other Intervention Name(s)
Group 1
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Part 2 Group 1
Other Intervention Name(s)
Group 1
Intervention Description
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Intervention Type
Drug
Intervention Name(s)
Part 2 group 2
Other Intervention Name(s)
Group 2
Intervention Description
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Intervention Type
Device
Intervention Name(s)
Part 2 group 3
Other Intervention Name(s)
Group 3
Intervention Description
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
Intervention Type
Device
Intervention Name(s)
Part 2 Group 4
Other Intervention Name(s)
Group 4
Intervention Description
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum observed drug concentration
Time Frame
14 days
Title
tmax
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate Klaus, MD
Organizational Affiliation
Baush and Lomb
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuvisan GmbH
City
Neu-Ulm
State/Province
Wegenerstrasse 13
ZIP/Postal Code
89231
Country
Germany

12. IPD Sharing Statement

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Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)

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