Scopolamine Patch Pharmacokinetics in Healthy Adults
Condition: Healthy
Intervention: Transderm Scop®; Intravenous scopolamine hydrobromide
Intervention description: TDDS dosage is 1.5 mg/72 hrs; 0.4 mg via intravenous injection
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Peer Review; Research

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or non-pregnant women of any ethnic background between the age of 18 and 65 years
             old.

          2. 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.

          3. Provide written informed consent before initiation of any study procedures.

          4. Available for follow-up for the planned duration of the study.

          5. Able to communicate well with the investigators.

          6. Able to adhere to the study protocol schedule, study restrictions and examination
             schedule.

          7. Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).

          8. 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.

          9. Subjects deemed to be healthy as judged by the Medically Accountable Investigator
             (MAI) and determined by medical history, physical examination, and medication history.

         10. Negative urine drug screening test.

         11. Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart
             rate (55-100 bpm).

         12. Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium,
             chloride, bicarbonate, BUN, creatinine, ALT, AST, and total bilirubin.

         13. Have normal screening laboratories for urine protein and urine glucose.

         14. 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.

         15. 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.

         16. Agrees not to donate blood to a blood bank throughout participation in the study and
             for at least 2 months after last procedure day.

         17. Have a normal ECG; must not have the following to be acceptable: pathologic Q wave
             abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right
             bundle branch block, left bundle branch block (sinus rhythm is between 55-100 beats
             per minute).

        Exclusion Criteria:

          1. 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.

          2. 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)).

          3. 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..

          4. 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

          5. 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.

          6. History of chronic obstructive pulmonary disease.

          7. Positive urine drug screening test.

          8. 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).

          9. 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).

         10. Donation or loss of greater than one pint of blood within 60 days of entry to the
             study.

         11. 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).

         12. Have a diagnosis of schizophrenia or other major psychiatric diagnosis.

         13. Received an experimental agent (vaccine, drug, biologic, device, blood product or
             medication) within 1 month before enrollment in this study or expects to receive an
             experimental agent during the study.

         14. Medical history of a serious chronic condition, including (but not limited to):
             allergic conditions such as anaphylaxis, asthma or generalized drug reactions; any
             seizure disorder; glaucoma (open or closed angle); history of pyloric or urinary
             bladder neck obstruction; intestinal obstruction; difficulty swallowing; stomach or
             bowel problems (e.g, blockage, muscle weakness, ulcerative colitis, Crohn's disease);
             bleeding disorders; acid reflux disease; myasthenia gravis; allergy to belladonna
             alkaloids; impaired hepatic or renal function.

         15. Any condition that would, in the opinion of the MAI, place the subject at an
             unacceptable risk of injury or render the subject unable to meet the requirements of
             the protocol.

         16. Inability to communicate or co-operate with the investigators.

         17. Medical history of significant dermatologic diseases or conditions, such as atopy,
             psoriasis, vitiligo or conditions known to alter skin appearance or physiologic
             response (e.g. diabetes, porphyria).

         18. History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma),
             except basal cell carcinomas that were superficial and did not involve the
             investigative site.

         19. History of consumption of alcohol within 24 hours prior to dose administration.

         20. Subject has an obvious difference in skin color between arms or the presence of a skin
             condition, excessive hair at the application site, sunburn, raised moles and scars,
             open sores at application site, scar tissue, tattoo, or coloration that would
             interfere with placement of test articles, skin assessment, or reactions to drug.

         21. Use of monoamine oxidase inhibitors 21 days prior to study.

         22. Within 4 weeks prior to dosing, 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 or agents deemed to be
             immunosuppressive as determined by physician investigator.

         23. Planned MRI scan of the head during TDDS wear.