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

Anaphylaxis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282929
• Other study ID #: N-A-PH1-15-050
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2017
• Est. completion date: October 15, 2018

Study information

• Verified date: June 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 15, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anaphylaxis

Intervention

Device:
• Part 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 1
300 µg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

Drug:
• Part 2 group 2
500 µg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

Device:
• Part 2 group 3
300 µg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
• Part 2 Group 4
300 µg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Neu-Ulm	Wegenerstrasse 13

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum observed drug concentration	14 days
Primary	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.	14 days