Healthy SubjectsPhase 1NCT07818330
A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
A Phase 1 study testing Dexmedetomidine Transdermal System (DMTS) in people with Healthy Subjects, run by Teikoku Pharma USA, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Dexmedetomidine Transdermal System (DMTS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 23 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Healthy Subjects
- Being tested
- Dexmedetomidine Transdermal System (DMTS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Transdermal System (DMTS)Drug
Dose: 2.92 mg dexmedetomidine Mode of Administration: Transdermal
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Transdermal System (DMTS) | Experimental | Not described Receives: Drug: Dexmedetomidine Transdermal System (DMTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs
Measured: From Day 1 to Day 15 (EOS visit)
Incidence of SAEs
Measured: From Day 1 to Day 15 (EOS visit)
Secondary outcomes (5)
Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)
Measured: 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)
Measured: 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.)
Measured: Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit)
Sedation effect of dexmedetomidine transdermal system (DMTS)
Measured: From Day 1 to Day 13
Adhesion of the dexmedetomidine transdermal system (DMTS)
Measured: From Day 1 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion9 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818330
- Sponsor's protocol ID
- TPU-DMT-01-1704
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07818330
- Acronym / sponsor ID
- TPU-DMT-01-1704
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Transdermal System (DMTS) | Experimental | Drug: Dexmedetomidine Transdermal System (DMTS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Transdermal System (DMTS)Dose: 2.92 mg dexmedetomidine Mode of Administration: Transdermal | Drug | Dexmedetomidine Transdermal System (DMTS) |
Primary outcome
Incidence of TEAEs
Time frame: From Day 1 to Day 15 (EOS visit)
Incidence of SAEs
Time frame: From Day 1 to Day 15 (EOS visit)
5 secondary outcomes
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)
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)
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)
Sedation effect of dexmedetomidine transdermal system (DMTS)
Time frame: From Day 1 to Day 13
Adhesion of the dexmedetomidine transdermal system (DMTS)
Time frame: From Day 1 to Day 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine Transdermal System (DMTS) in people with Healthy Subjects, run by Teikoku Pharma USA, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tami Ujiie (+1 408 501 1822, tujiie@teikokuusa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (time frame: From Day 1 to Day 15 (EOS visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.