A healthy volunteer study to determine the maximum tolerable dose of the dexmedetomidine transdermal system and how much is available in the body.

Phase 1

• Conditions: Acute pain management in perioperative setting.; Anaesthesiology - Pain management

• Registration Number: ACTRN12616000472471
• 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: 2016-04-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1.Healthy male or female subjects 18 to 45 years of age, inclusive.
2.Subjects must be non-smokersfor at least 1 year prior to screening.
3.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. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy, a bilateral tubal ligation and/or a bilateral oophorectomy. Male subjects who are not surgically sterile and have female partners of childbearing potential must ensure that they and their partners use the methods of contraception outlined above.
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.
10.Use of any prescription drug within 14 days of the first study drug administration and throughout the study.
11.Use of any prescription or non-prescription product containing any sympathomimetic amine (eg, pseudoephedrine, phenylephrine, and others commonly found in cold preparations) within 14 days prior to the first study drug administration and throughout the study.
12.Use of any prescription medications or natural health products (except vitamin or mineral supplements, or acceptable forms of birth control) within 14 days prior to the first 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.
13.Use of a non-prescription drug within 7 days prior to the first 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.
14.Positive test result for drugs of abuse at screening or prior to study drug dosing.
15.Positive alcohol test at screening or prior to study drug dosing.
16.Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration.
17.History of allergy or hypersensitivity to dexmedetomidine or dexmedetomidine hydrochloride.
18.Positive for hepatitis B, hepatitis C, or the human

Study & Design

• Study Type: Interventional
• Study Design: Not specified