An Ascending Dose Study of the Dexmedetomidine TransdermalSystem in Healthy Subjects

Phase 1

Completed

• Conditions: Acute Pain Management in postoperative setting; Anaesthesiology - Pain management

• Registration Number: ACTRN12619000476134
• 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: 2019-03-22
• Study Completion: 2019-06-30
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Healthy male or female subjects, 18 to 60 years of age, inclusive.
2. Subjects must be non-smokers, as defined by cessation of smoking and consumption of no more
than 2 tobacco/nicotine-containing products (including chewing tobacco, snuff, e-cigarettes, nicotine patches, etc.) within 6 months prior to screening.
3. Have a body weight greater than 50 kg, and body mass index of 18.0 to 38.0, inclusive.
4. Free of any dermatologic conditions (for example, psoriasis, eczema), excessive hair, skin allergies, or sensitivities that may compromise the subject’s ability to wear the investigational product at the application sites for the specified duration of treatment.
5. Female subjects are eligible only if all the following apply:
a. Not pregnant, not lactating, and not planning to become pregnant during the study or for
1 menstrual cycle thereafter
b. Surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a monogamous same gender sex partner; or is using 2 highly effective forms of contraception, such as an insertable, injectable, transdermal, combination oral contraceptive, and male condom. Contraception should be used for 1 month prior to the study, during the study, and for 1 month following the study.
6. Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to the use of a reliable method of birth control during the study and for 1 month following the study.
7. 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. Voluntarily provide written informed consent, prior to the initiation of any protocol-specific procedures.
9. 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 and nicotine), 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 , medical history, 12-lead electrocardiogram, vital signs, laboratory values, including serum kidney and liver function tests.
3. Supine heart rate less than 60 or greater than 100 bpm, systolic blood pressure (BP) less than 90 or greater than 140 mmHg, or diastolic BP less than 60 or greater than 90 mmHg, when measured after being supine for at least 5 minutes
4. Presence and or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing.
5. Subjects with a history of seizures, asthma (except for childhood asthma which has been
asymptomatic for greater than or equal to 10 years), or obstructive pulmonary disease.
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/disorder (including suicidal ideation and behavior, organic brain disorder, or seizure disorder), 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 (for example, scar, tattoo) or unhealthy skin (for example, 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 prescription drug (except acceptable forms of birth control) within 14 days prior to study drug administration and throughout the study.
10. Use of any prescription or non-prescription product containing any sympathomimetic amine (for example, pseudoephedrine, phenylephrine, and others commonly found in cold preparations) within 14 days prior to study drug administration and throughout the study.
11. Use of any natural health products (except vitamin or mineral supplements) within 14 days prior to study drug administration and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity, or compromise the safety of the subject.
12. Use of a non-prescription drug within 7 days prior to study drug administration; subjects who have taken over-the-counter medications, other than those described above, may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity, or compromise the safety of the subject.
13. Positive test result for drugs of abuse at screening or prior to study drug dosing (testing can be repeated at the discretion of the investigator).
14. Positive alcohol test at screening or prior to study drug dosing.
15. Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration.
16. History of allergy or hypersensitivity to dexmedetomidin

Study & Design

• Study Type: Interventional
• Study Design: Not specified