Status:
UNKNOWN
Scopolamine in Healthy Volunteers
Lead Sponsor:
Repurposed Therapeutics, Inc.
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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...
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 Coho...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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),
- 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).
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03874130
Start Date
August 1 2018
End Date
May 1 2020
Last Update
February 17 2020
Active Locations (1)
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1
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806