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

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Anaphylaxis

Treatments: Drug: Part 2 group 2; Device: Part 2 Group 1; Device: Part 2 Group 4; Device: Part 2 group 3; Device: Part 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03282929

N-A-PH1-15-050

Details and patient eligibility

About

A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects

Full 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

Enrollment: 43 patients

Sex: All

Ages: 18 to 54 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 5 patient groups

Part 1 Group 1

Experimental group

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.

Treatment:

Device: Part 1

Part 2 group 1

Experimental group

Description:

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

Treatment:

Device: Part 2 Group 1

Part 2 Group 2

Experimental group

Description:

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

Treatment:

Drug: Part 2 group 2

Part 2 Group 3

Experimental group

Description:

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

Treatment:

Device: Part 2 group 3

Part 2 Group 4

Experimental group

Description:

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

Treatment:

Device: Part 2 Group 4