Clinical trial NCT03282929: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anaphylaxis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Cmax
timeFrame: 14 days
measure: tmax
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
state: Wegenerstrasse 13
Study officials:
affiliation: Baush and Lomb
name: Beate Klaus, MD
role: PRINCIPAL_INVESTIGATOR
References: