Healthy Subjects
Conditions
Brief summary
This Phase 1, 16-day Repeat dose study will evaluate the safety of a Dexmedetomidine Transdermal System (DMTS) skin system in healthy adults Subjects. Participants will receive the patch for four consecutive 4-day treatment periods. Researchers will monitor safety, drug levels in the blood, sedation effects, skin irritation, and how well the patch stays attached to the skin.
Interventions
DRUGDexmedetomidine Transdermal System (DMTS)
Dose: 2.92 mg dexmedetomidine Mode of Administration: Transdermal
Sponsors
Teikoku Pharma USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be non-smokers, as defined by cessation of smoking and consumption of no more than 2 tobacco/nicotine-containing products within 6 months prior to screening. * Have a body weight \> 50 kg, and body mass index (BMI) of 18.0 to 38.0 kg/m2 * 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 the application site for the specified duration of treatment * Female subjects are eligible only if all the following apply: 1. Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter 2. Surgically sterile (via hysterectomy or oophorectomy); or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a same gender partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study * Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 3 months following the study.
Exclusion criteria
* History of allergy or hypersensitivity to dexmedetomidine or dexmedetomidine hydrochloride. * Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS application site, according to examination by the investigator at screening or admission to the clinic. * History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * History of seizures. * Use of any prescription or non-prescription drugs (except acceptable forms of birth control, paracetamol up to 2 g per day for no more than 3 consecutive days, and ibuprofen up to 1.2 g per day for no more than 3 consecutive days for headache or dysmenorrhea, etc., per investigator discretion) 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 * Significant history of postural hypotension, or history of severe dizziness or fainting upon standing in the opinion of the investigator. * Donation of blood or loss of blood (\> 100 mL) within 30 days prior to study drug administration. * Had symptoms of an upper respiratory tract infection within 14 days prior to dosing of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TEAEs | From Day 1 to Day 15 (EOS visit) |
| Incidence of SAEs | From Day 1 to Day 15 (EOS visit) |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles) | Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit) |
| Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration) | Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit) |
| Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.) | Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit) |
| Sedation effect of dexmedetomidine transdermal system (DMTS) | From Day 1 to Day 13 |
| Adhesion of the dexmedetomidine transdermal system (DMTS) | From Day 1 to Day 13 |
Contacts
CONTACTTami Ujiie
Outcome results
None listed