Major Depressive Disorder (MDD)Phase 1NCT03874130
Scopolamine in Healthy Volunteers
A Phase 1 study testing Scopolamine in people with Major Depressive Disorder (MDD), run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial summary
This single-site clinical trial is an open-label study to identify the safety and pharmacokinetics of DPI-386 Nasal Gel (intranasal scopolamine gel) and IV Scopolamine. The study will require subjects to receive either multiple doses of 0.2 mg or a single dose of 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, or 1.2 mg of DPI-386… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Scopolamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated ICF.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 40 (inclusive).
- Males and females must agree to use highly effective contraception (e.g. double barrier method) for 4 weeks after receiving the last dose of treatment.
- Have a body mass index (BMI) within a range of 18 to 30 inclusive.
- In good general health as evidenced by medical history with no recent history or current diagnosis of significant cardiovascular or respiratory problems as assessed by the PI or qualified designee.
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- Hematology, biochemistry, urinalysis and drug and alcohol laboratory test results that are determined by the PI or qualified designee to be not clinically significant.
- Ability to take intranasal medication (for Cohorts 1-4, and 6-15 only) and willingness to adhere to the study schedule and time constraints.
- For females of child-bearing potential: willingness to provide a sample for the pregnancy test upon every visit. Test must be negative.
- Note: Women of non-childbearing potential are defined as those who are non-surgically sterile (i.e., without menses for at least 12 consecutive months) or surgically sterile (i.e., those who underwent a hysterectomy with or without oophorectomy, fallopian tube ligation, and endometrial ablation).
- Agreement to adhere to the following lifestyle compliance considerations:
- Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the treatment day.
- Caffeine intake limited to 300 mg on treatment day (two 8-ounce cups).
- Abstain from alcohol for 24 hours prior to first dose of study medication.
- Refrain from any type of nicotine within 30 days prior to the screening visit and through the completion of the treatment day.
Who cannot join
- Pregnancy, lactation, or positive serum pregnancy test at screening.
- Known allergic reactions to scopolamine or other anticholinergics.
- Currently prescribed any of the following medication types and used within the specified washout periods below:
- belladonna alkaloids (washout 2 weeks),
- antihistamines (including meclizine) (washout 2 weeks),
- tricyclic antidepressants (washout 2 weeks),
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- muscle relaxants (washout 4 days) and
- nasal decongestants (washout 4 days) (for Cohorts 1-4, and 6-16 only).
- Hospitalization or significant surgery requiring hospital admittance within the past six months.
- Treatment with another investigational drug or other intervention within the past 30 days.
- Having donated blood or plasma or suffered significant blood loss within the past 30 days.
- Use of nicotine within 30 days prior to the screening visit.
- Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or qualified designee:
- Significant gastrointestinal disorder, asthma, or seizure disorders.
- History of narrow-angle glaucoma.
- History of urinary retention or clinically significant symptomatic benign prostatic hypertrophy (BPH).
- History of moderate or severe substance use disorder.
- Nasal, nasal sinus, or nasal mucosa surgery (for Cohorts 1-4, and 6-16 only).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Jay Saifuki, 562-304-1740
About this study
Official title: Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers
This single-site clinical trial is an open-label study to identify the safety and pharmacokinetics of DPI-386 Nasal Gel (intranasal scopolamine gel) and IV Scopolamine. The study will require subjects to receive either multiple doses of 0.2 mg or a single dose of 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, or 1.2 mg of DPI-386 Nasal Gel or 0.4 mg/mL IV Scopolamine per the assigned treatment cohort. Multiple PK blood draws will be collected dependent on cohort assignment. Vital signs and ECGs will be collected. No efficacy will be tested. Subjects will be monitored for at least eight hours after the final dose. There could be up to 160 subjects enrolled stratified equally by gender.
Screening will not occur until after subjects have signed the informed consent form (ICF). Screening will include hematology, biochemistry, urinalysis, alcohol and drug screen, physical examination, including vital signs and ECG, and review of medical history by the PI or qualified designee, serum pregnancy test as applicable, and agreement to adhere to the study lifestyle requirements.
Subject data will be recorded in the source documents and appropriate eCRF.
Read the detailed description
The investigational product is a combination product comprised of: (a) a vial prefilled with DPI-386 Nasal Gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. For Cohorts 1 through 4, 9 through 10,13, and 14 each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. For Cohorts 1 through 4, 9, 10 and 13 through 16 each vial of DPI-386 Nasal Gel is a multi-dose product, sufficient for six individual doses. Each pumping action is designed to deliver a single 0.12 g dose. The DPI-386 Nasal Gel for Cohorts 1 through 4, 13 and 14 is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". For Cohort 6 the dose is "0.8 mg / 0.12 g", and for cohort 7 the dose is "1.0 mg / 0.12 g", and for Cohort 8 the dose is "1.2 mg / 0.12 g", and for Cohort 11 the dose is "0.4 mg / 0.12 g", and for Cohort 12 and 15 the dose is "0.6 mg / 0.12 g", delivered in a single dose, and for Cohort 16 the dose is "0.6 mg / 0.12 g", in a modified excipient formulation, delivered in a single dose.
For Cohort 16 only: Each 0.12 gram of the gel contains 0.6 mg of scopolamine HBr as the active ingredient along with a modified formulation of excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride 100, polyvinyl alcohol 18, and purified water.
Each vial/pump unit must be primed by research staff prior to first dose delivery. Subjects will self-administer the drug under guidance from the study staff.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Scopolamine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopolamineDrug
Also called scopolamine HBr
IV Scopolamine
| Study group | Role | What they receive |
|---|---|---|
| Scopolamine | Active comparator | 0.2 mg scopolamine HBr per dose Receives: Drug: Scopolamine |
| IV Scopolamine | Active comparator | 4.0 μg/kg; 15 minute IV infusion Receives: Drug: Scopolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the safety of Scopolamine HBr
Safety will be evaluated in terms of adverse events. Number of patients that report events of special interest as listed in the protocol.
Measured: The duration of participation for each subject will be approximately two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Aug 2018
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Helton, Study director, Repurposed Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874130
- Sponsor's protocol ID
- DPI-386-DE-10
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2018
- Last updated
- 17 Feb 2020
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03874130
- Acronym / sponsor ID
- DPI-386-DE-10
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 14 Mar 2019 (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 single-site clinical trial is an open-label study to identify the safety and pharmacokinetics of DPI-386 Nasal Gel (intranasal scopolamine gel) and IV Scopolamine. The study will require subjects to receive either multiple doses of 0.2 mg or a single dose of 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, or 1.2 mg of DPI-386 Nasal Gel or 0.4 mg/mL IV Scopolamine per the assigned treatment cohort. Multiple PK blood draws will be collected dependent on cohort assignment. Vital signs and ECGs will be collected. No efficacy will be tested. Subjects will be monitored for at least eight hours after the final dose. There could be up to 160 subjects enrolled stratified equally by gender.
Screening will not occur until after subjects have signed the informed consent form (ICF). Screening will include hematology, biochemistry, urinalysis, alcohol and drug screen, physical examination, including vital signs and ECG, and review of medical history by the PI or qualified designee, serum pregnancy test as applicable, and agreement to adhere to the study lifestyle requirements.
Subject data will be recorded in the source documents and appropriate eCRF.
Detailed description
The investigational product is a combination product comprised of: (a) a vial prefilled with DPI-386 Nasal Gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. For Cohorts 1 through 4, 9 through 10,13, and 14 each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. For Cohorts 1 through 4, 9, 10 and 13 through 16 each vial of DPI-386 Nasal Gel is a multi-dose product, sufficient for six individual doses. Each pumping action is designed to deliver a single 0.12 g dose. The DPI-386 Nasal Gel for Cohorts 1 through 4, 13 and 14 is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". For Cohort 6 the dose is "0.8 mg / 0.12 g", and for cohort 7 the dose is "1.0 mg / 0.12 g", and for Cohort 8 the dose is "1.2 mg / 0.12 g", and for Cohort 11 the dose is "0.4 mg / 0.12 g", and for Cohort 12 and 15 the dose is "0.6 mg / 0.12 g", delivered in a single dose, and for Cohort 16 the dose is "0.6 mg / 0.12 g", in a modified excipient formulation, delivered in a single dose.
For Cohort 16 only: Each 0.12 gram of the gel contains 0.6 mg of scopolamine HBr as the active ingredient along with a modified formulation of excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride 100, polyvinyl alcohol 18, and purified water.
Each vial/pump unit must be primed by research staff prior to first dose delivery. Subjects will self-administer the drug under guidance from the study staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scopolamine | Active comparator | Drug: Scopolamine0.2 mg scopolamine HBr per dose |
| IV Scopolamine | Active comparator | Drug: Scopolamine4.0 μg/kg; 15 minute IV infusion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Provision of signed and dated ICF.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 40 (inclusive).
- Males and females must agree to use highly effective contraception (e.g. double barrier method) for 4 weeks after receiving the last dose of treatment.
- Have a body mass index (BMI) within a range of 18 to 30 inclusive.
Key exclusion criteria (18 listed)
- Pregnancy, lactation, or positive serum pregnancy test at screening.
- Known allergic reactions to scopolamine or other anticholinergics.
- Currently prescribed any of the following medication types and used within the specified washout periods below:
- Hospitalization or significant surgery requiring hospital admittance within the past six months.
- Treatment with another investigational drug or other intervention within the past 30 days.
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 |
|---|---|---|
| ScopolamineAlso: scopolamine HBrIV Scopolamine | Drug | IV Scopolamine, Scopolamine |
Primary outcome
Describe the safety of Scopolamine HBr
Time frame: The duration of participation for each subject will be approximately two weeks.
Safety will be evaluated in terms of adverse events. Number of patients that report events of special interest as listed in the protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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. This study is not recruiting at the moment.
David R Helton study director
Repurposed Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Scopolamine in people with Major Depressive Disorder (MDD), run by Repurposed Therapeutics, Inc. at 1 site in United States.
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 15 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Ferguson ((919) 694-5454, mferguson@tabclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the safety of Scopolamine HBr (time frame: The duration of participation for each subject will be approximately two weeks.). 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 17 Feb 2020.