Scopolamine in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Repurposed Therapeutics, Inc.
• Treatments: Butylscopolammonium Bromide; Scopolamine

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 6-15 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 6-16 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 6-16 only).