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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.

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
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.
Change History Complete list of historical versions of study NCT03874130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Scopolamine in Healthy Volunteers
Official Title  ICMJE Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder (MDD)
Intervention  ICMJE Drug: Scopolamine
IV Scopolamine
Other Name: scopolamine HBr
Study Arms  ICMJE
  • Active Comparator: Scopolamine
    0.2 mg scopolamine HBr per dose
    Intervention: Drug: Scopolamine
  • Active Comparator: IV Scopolamine
    4.0 μg/kg; 15 minute IV infusion
    Intervention: Drug: Scopolamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Laurie Mellott 949-428-6600 laurie.mellott@clindatrix.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874130
Other Study ID Numbers  ICMJE DPI-286-DE-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Repurposed Therapeutics, Inc.
Study Sponsor  ICMJE Repurposed Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Repurposed Therapeutics, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP