CompletedPhase 1ACTRN12615001168549

A First In Human study to compare 2 formulations of dexmedetomidine

An Open-label, Randomized, Two-period, Cross-over Study to Assess the Bioavailability, Safety, and Tolerability of the Dexmedetomidine Transdermal System (DMTS) versus Intravenous Dexmedetomidine in Healthy Subjects

Sponsor

Clinical Network Services Pty Ltd

Enrollment

12 participants

Start Date

Nov 17, 2015

Study Type

Interventional

Conditions

Pain Management

Summary

This is a first in human study for the DMTS. This study is evaluating a different formulation of dexmedetomidine by determining the bioavailability and pharmacokinetics of dexmedetomidine following a single 3-day application of the DMTS compared with a 24 hour IV infusion of Precedex and assessing the safety and tolerability. This is an open-label, randomized, two-period, cross-over study.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria10

Healthy male or female subjects 18 to 45 years of age, inclusive.
Subjects must be non-smokers, as defined by cessation of smoking and use of all other tobacco and nicotine products (including chewing tobacco, snuff, e-cigarettes, nicotine patches, etc.) for at least 1 year prior to screening.
Body mass index (BMI) within the range of 18 to 29 kg/m2, inclusive, and a weight of at least 50 kg.
Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair, skin allergies, or sensitivities that may compromise the subject’s ability to wear the investigational product at any of the application sites for the specified duration of treatment.
Female subjects of childbearing potential must be practicing abstinence or using and willing to continue using a medically acceptable form of contraception for at least
month prior to screening (at least 3 months for oral contraceptives) and for at least 30 days after the last study drug administration.
Female subjects must have a negative serum pregnancy test at screening and prior to dosing.
Must be able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
Must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria10

A history or presence of drug or alcohol dependence (excluding caffeine), including subjects who have ever been in a drug rehabilitation program based on medical history of the past 10 years.
Clinically significant abnormalities as judged by the investigator or designee and determined by physical examination (PE), medical history, 12-lead electrocardiogram
(ECG), vital signs, laboratory values, including serum kidney and liver function tests.
Presence of postural hypotension (determined through examination by the investigator or designee), or recent history of severe dizziness or fainting due to postural hypotension on standing.
Subjects with a history of seizures, asthma, or obstructive pulmonary disease.
Presence or history of any of the following disorders that are deemed clinically significant by the investigator or designee: a psychiatric disorder (including suicidal ideation and behavior), organic brain disorder, or seizure disorder.
Presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including ulcers or gastrointestinal bleeding), endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
Abnormality (eg, scar, tattoo) or unhealthy skin (eg, burns, wounds) at the application site, according to examination by the investigator at screening, admission to the clinic, or prior treatment period of the study.
An existing chronic skin disease or history of skin disease at the application site within the 30 days prior to screening.
Use of any drugs containing estrogens within 30 days prior to the first study drug administration and throughout the study.

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Interventions

Dexmedetomidine Transdermal System (DMTS): The DMTS is a patch that contains 7.32 mg of dexemedetomidine. Based on the non-clinical data, the expected delivered dose is 1.44 mg at an average rate o

Dexmedetomidine Transdermal System (DMTS): The DMTS is a patch that contains 7.32 mg of dexemedetomidine. Based on the non-clinical data, the expected delivered dose is 1.44 mg at an average rate of 20 mcg/h over three days. The patch will be checked for integrity at 6, 12, 24, 48 hours after application, and immediately prior to patch removal. There will be a minimum washout period of 2 days.