A First In Human study to compare 2 formulations of dexmedetomidine

Phase 1

Completed

• Conditions: Pain Management; Anaesthesiology - Pain management

• Registration Number: ACTRN12615001168549
• Lead Sponsor: Clinical Network Services Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.Healthy male or female subjects 18 to 45 years of age, inclusive.
2.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.
3.Body mass index (BMI) within the range of 18 to 29 kg/m2, inclusive, and a weight of at least 50 kg.
4.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.
5.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
1 month prior to screening (at least 3 months for oral contraceptives) and for at least 30 days after the last study drug administration.
6.Female subjects must have a negative serum pregnancy test at screening and prior to dosing.
7.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.
8.Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
9.Must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria

1.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.
2.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.
3.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.
4.Subjects with a history of seizures, asthma, or obstructive pulmonary disease.
5.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.
6.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.
7.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.
8.An existing chronic skin disease or history of skin disease at the application site within the 30 days prior to screening.
9.Use of any drugs containing estrogens within 30 days prior to the first study drug administration and throughout the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the bioavailability profile of dexmedetomidine following a single 3-day application of the DMTS compared with a 24-hour IV infusion of Precedex by determining the blood level of dexmedetomidine. [While on patch treatment, blood levels will be evaluated at:<br>pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, and 60 hours after application; before patch removal, 0.5, 1, 2, 3, 4, 6, 9, and 12 hours after patch removal.<br>];The primary outcome is the pharmacokinetic profile of dexmedetomidine following a single 3-day application of the DMTS compared with a 24-hour IV infusion of Precedex by determining pharmacokinetic parameters (Tmax, Cmax, AUC, and half-life) with blood samples[When on IV Precedex treatment, blood levels will be evaluated at:<br>predose, 5, 10, 15, 30, 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion; 5, 10, 15, 30, 45 minutes, 1, 2, 3, 4, 6, and 8 hours after the end of the infusion. <br>]