Scopolamine Patch Pharmacokinetics in Healthy Adults

NCT03029650 | Completed Phase 4 Results

• 1 other identifier: 201506778
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.

Conditions

Healthy

Keywords

Peer Review; Research

Outcome Measures

Primary Outcomes (1)

• Measurement of Maximum Serum Concentration of Scopolamine (Cmax)

  Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr

Secondary Outcomes (6)

• Assessment of Scopolamine Clearance (CL)

  Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr

• Measurement of Volume of Scopolamine Distribution (V)

  Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr

• Measurement of Elimination Rate Constant of Scopolamine (Kel)

  Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr

• Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)

  Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr

• Determination of Area Under the Serum Concentration-time Curve (AUC)

  Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBr

Study Arms (2)

Transderm Scop®

ACTIVE COMPARATOR

Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between. Subjects will be randomized to Group 1 (Transderm Scop® first followed by intravenous scopolamine hydrobromide) and remaining subjects will be randomized to Group 2 (intravenous scopolamine hydrobromide first followed by Transderm Scop®).

Drug: Transderm Scop®; Drug: Intravenous scopolamine hydrobromide

Intravenous scopolamine hydrobromide

EXPERIMENTAL

Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between. Subjects will be randomized to Group 1 (Transderm Scop® first followed by intravenous scopolamine hydrobromide) and remaining subjects will be randomized to Group 2 (intravenous scopolamine hydrobromide first followed by Transderm Scop®).

Drug: Transderm Scop®; Drug: Intravenous scopolamine hydrobromide

Interventions

Transderm Scop® DRUG

TDDS dosage is 1.5 mg/72 hrs

Intravenous scopolamine hydrobromide; Transderm Scop®

Intravenous scopolamine hydrobromide DRUG

0.4 mg via intravenous injection

Intravenous scopolamine hydrobromide; Transderm Scop®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or non-pregnant women of any ethnic background between the age of 18 and 65 years old.
• Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and are not currently using tobacco products.
• Provide written informed consent before initiation of any study procedures.
• Available for follow-up for the planned duration of the study.
• Able to communicate well with the investigators.
• Able to adhere to the study protocol schedule, study restrictions and examination schedule.
• Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
• Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
• Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
• Negative urine drug screening test.
• Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm).
• Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST, and total bilirubin.
• Have normal screening laboratories for urine protein and urine glucose.
• Female subjects must be of non-childbearing potential (defined as surgically sterile \[i.e. history of hysterectomy or tubal ligation\] or postmenopausal for more than 1 year \[no bleeding for 12 consecutive months\]), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of the first day of each study treatment session, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
• Agrees not to participate in another clinical study during the study period unless the study is in the follow up phase and it has been 1 month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 1 month after last procedure day.

You may not qualify if:

• Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any procedure session.
• Smokers (current use or use over the previous 12 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)).
• Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow up phase and it has been ≥ 1 month since the subject received any experimental agents or treatments..
• Abnormal vital signs, defined as:
• Hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) at rest on 2 separate days.
• Heart rate \<55 at rest on 2 separate days
• Respiratory rate ≤ 11 to ≥ 18 breaths per minute
• Temperature \>38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the scopolamine TDDS.
• History of chronic obstructive pulmonary disease.
• Positive urine drug screening test.
• Use of any prescription medication during the period 0 to 30 days or over-the counter medication during the period 0 to 3 days before entry to the study (vitamins, herbal supplements and birth control medications not included).
• Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product (e.g. antihistamines \[within 72 hours prior to dosing\], systemic or topical corticosteroids \[within 3 weeks prior to dosing\], cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin \[BCG\], monoclonal antibodies, radiation therapy).
• Donation or loss of greater than one pint of blood within 60 days of entry to the study.
• Any prior serious adverse reaction or hypersensitivity to scopolamine, or any of the inactive ingredients in the TDDS (light mineral oil, polyisobutylene, polypropylene and aluminized polyester film).
• Have a diagnosis of schizophrenia or other major psychiatric diagnosis.

Sponsors & Collaborators

• University of Iowa: lead
• University of Minnesota: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Scopolamine

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

Results Point of Contact

• Title: Nicole Brogden
• Organization: University of Iowa

nicole-brogden@uiowa.edu

319-335-8752

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 24, 2017
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: March 1, 2018
• Last Updated: June 21, 2018
• Results First Posted: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)