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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

About this trial

This is an interventional treatment trial for Anaphylaxis

Eligibility Criteria

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

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).

Sites / Locations

Nuvisan GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

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

NCT ID

NCT03282929

First Posted

July 21, 2017

Last Updated

June 20, 2019

Sponsor

Bausch & Lomb Incorporated

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Learn more about this trial

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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