DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness

NCT04219982 | Terminated Phase 2 FDA Drug

• 1 other identifier: DPI-386-07
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (1)

• The length of time spent in mechanical rotation until nausea (inclination to vomit) is achieved, or 20 minutes have elapsed.

  up to 20 minutes

Study Arms (3)

DPI-386 Nasal Gel

EXPERIMENTAL

Active DPI-386 Nasal Gel

Drug: DPI-386 Nasal Gel

DPI-386 Placebo Nasal Gel

PLACEBO COMPARATOR

Placebo Nasal Gel

Drug: DPI-386 Placebo Nasal Gel

Transderm Scop® (TDS)

ACTIVE COMPARATOR

FDA approved Transderm Scop® (TDS).

Drug: Transderm Scop®

Interventions

DPI-386 Nasal Gel DRUG

Nasal gel

DPI-386 Nasal Gel

DPI-386 Placebo Nasal Gel DRUG

DPI-386 Placebo Nasal Gel

DPI-386 Placebo Nasal Gel

Transderm Scop® DRUG

Transderm Scop®

Transderm Scop® (TDS)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated ICD.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 to 59 (inclusive).
• Active duty military, reserves on active status, or dependents covered by Tricare health insurance. All potential subjects must be able to provide a current military or DoD dependent ID to be viewed by the PI or qualified designee prior to signing the ICD.
• At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
• In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems that would affect rotation in a vestibular study (e.g., vestibular pathology, seizure disorder, sinus congestion), as assessed by the PI or qualified designee.
• Laboratory test results that are determined by the PI or qualified designee to be normal or - if slightly out of the normal range - determined to be not clinically significant. The following laboratory tests will be performed:
• Hematology panel (WBC, RBC, HGB, Hct)
• Biochemistry panel (liver function: bilirubin \[total and direct\], ALT, AST, ALP, and GGT; Albumin, Creatinine, BUN, and Cortisol)
• Electrolytes (Na+, K+, Cl-, Ca2+, and PO4)
• Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
• For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test upon every visit to NAMRU-D. Test must be negative.
• Agreement to adhere to the following lifestyle considerations:
• Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the six treatment days.
• Caffeine intake limited to 900 mg per day (six 8-ounce cups per day \[daily total of 1.4 liters\]) during the six treatment days.

You may not qualify if:

• \. Pregnancy, lactation, or positive urine pregnancy test at screening.
• \. Known allergic reactions to scopolamine or other anticholinergics.
• \. Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, muscle relaxants and nasal decongestants.
• \. 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 a nicotine patch. 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:
• Significant gastrointestinal disorder, asthma, or seizure disorders.
• History of vestibular disorders.
• History of narrow-angle glaucoma.
• History of urinary retention.
• History of alcohol or drug abuse.
• Nasal, nasal sinus, or nasal mucosa surgery.

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead

Study Sites (1)

NAMRU-D

Dayton, Ohio, 45433, United States

Location

MeSH Terms

Conditions

Motion Sickness

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• David Helton

  Repurposed Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study is double-blinded for the DPI-386 Nasal Gel and placebo nasal gel arms. All DPI-386 Nasal Gel and placebo nasal gel vials are opaque and indistinguishable. The DPI-386 Nasal Gel and placebo nasal gel are identical in color and viscosity, and without identifiable smell.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The sample size of 54 allows for an equal distribution of subjects within gender and treatment arm: 18 subjects per treatment arm with 9 per gender.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: January 7, 2020
• Study Start: June 29, 2018
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

US (1)