Scopolamine in Healthy Volunteers

Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Age Range:18 - 40
Start Date:August 1, 2018
End Date:March 2019
Contact:Laurie Mellott

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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 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.

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.

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

6. Having donated blood or plasma or suffered significant blood loss within the past 30

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).
We found this trial at
Long Beach, California 90806
Phone: 562-304-1740
Long Beach, CA
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