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

NCT03282929 | Completed Phase 1

• 1 other identifier: N-A-PH1-15-050
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Anaphylaxis

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum observed drug concentration

  14 days

• 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

Study Arms (5)

Part 1 Group 1

EXPERIMENTAL

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

Part 2 group 1

EXPERIMENTAL

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

Device: Part 2 Group 1

Part 2 Group 2

EXPERIMENTAL

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

Drug: Part 2 group 2

Part 2 Group 3

EXPERIMENTAL

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

Device: Part 2 group 3

Part 2 Group 4

EXPERIMENTAL

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

Device: Part 2 Group 4

Interventions

Part 1 DEVICE

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

Part 1 Group 1

Part 2 Group 1 DEVICE

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

Also known as: Group 1

Part 2 group 1

Part 2 group 2 DRUG

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

Also known as: Group 2

Part 2 Group 2

Part 2 group 3 DEVICE

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

Also known as: Group 3

Part 2 Group 3

Part 2 Group 4 DEVICE

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

Also known as: Group 4

Part 2 Group 4

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Wegenerstrasse 13, 89231, Germany

Location

MeSH Terms

Conditions

Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Beate Klaus, MD

  Baush and Lomb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: September 14, 2017
• Study Start: March 23, 2017
• Primary Completion: September 28, 2018
• Study Completion: October 15, 2018
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

DE (1)