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A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects

ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTeikoku Pharma USA, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dexmedetomidine Transdermal System (DMTS)

    Drug

    Dose: 2.92 mg dexmedetomidine Mode of Administration: Transdermal

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Dexmedetomidine Transdermal System (DMTS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of TEAEs

Time frame
From Day 1 to Day 15 (EOS visit)
2

Incidence of SAEs

Time frame
From Day 1 to Day 15 (EOS visit)

Secondary outcomes

1

Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)

Time frame
Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit)
2

Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)

Time frame
Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit)
3

Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)

Time frame
Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit)
4

Sedation effect of dexmedetomidine transdermal system (DMTS)

Time frame
From Day 1 to Day 13

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Teikoku Pharma USA, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: