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Scopolamine in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03874130
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Repurposed Therapeutics, Inc.

Brief 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 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 120 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: Scopolamine Phase 1

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, and 13 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 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 and 13 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 the dose is "0.6 mg / 0.12 g", delivered in a single dose.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Scopolamine
0.2 mg scopolamine HBr per dose
Drug: Scopolamine
IV Scopolamine
Other Name: scopolamine HBr

Active Comparator: IV Scopolamine
4.0 μg/kg; 15 minute IV infusion
Drug: Scopolamine
IV Scopolamine
Other Name: scopolamine HBr




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of signed and dated ICF.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female, aged 18 to 40 (inclusive).
  4. 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.
  5. Have a body mass index (BMI) within a range of 18 to 30 inclusive.
  6. 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.
  7. Hematology, biochemistry, urinalysis and drug and alcohol laboratory test results that are determined by the PI or qualified designee to be not clinically significant.
  8. Ability to take intranasal medication (for Cohorts 1-4, and 6-12 only) and willingness to adhere to the study schedule and time constraints.
  9. 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).

  10. Agreement to adhere to the following lifestyle compliance considerations:

    1. Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the treatment day.
    2. Caffeine intake limited to 300 mg on treatment day (two 8-ounce cups).
    3. Abstain from alcohol for 24 hours prior to first dose of study medication.
    4. Refrain from any type of nicotine within 30 days prior to the screening visit and through the completion of the treatment day.

Exclusion Criteria:

  1. Pregnancy, lactation, or positive serum pregnancy test at screening.
  2. Known allergic reactions to scopolamine or other anticholinergics.
  3. 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),
    • muscle relaxants (washout 4 days) and
    • nasal decongestants (washout 4 days) (for Cohorts 1-4, and 6-12 only).
  4. Hospitalization or significant surgery requiring hospital admittance within the past six months.
  5. Treatment with another investigational drug or other intervention within the past 30 days.
  6. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
  7. Use of nicotine within 30 days prior to the screening visit.
  8. 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:

    1. Significant gastrointestinal disorder, asthma, or seizure disorders.
    2. History of narrow-angle glaucoma.
    3. History of urinary retention or clinically significant symptomatic benign prostatic hypertrophy (BPH).
    4. History of moderate or severe substance use disorder.
    5. Nasal, nasal sinus, or nasal mucosa surgery (for Cohorts 1-4, and 6-12 only).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874130


Contacts
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Contact: Laurie Mellott 949-428-6600 laurie.mellott@clindatrix.com

Locations
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United States, California
Collaborative Neuroscience Network, LLC Recruiting
Long Beach, California, United States, 90806
Contact: Jay Saifuki    562-304-1740      
Sponsors and Collaborators
Repurposed Therapeutics, Inc.

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Responsible Party: Repurposed Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03874130     History of Changes
Other Study ID Numbers: DPI-286-DE-10
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics