Study to Compare the Pharmacokinetics of a Dexamethasone Iontophoretic Patch to a Dexamethasone Injection

A Randomized, Open-Label, Single Dose, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Safety of a Dexamethasone Iontophoretic Transdermal Patch Compared to Dexamethasone Injection in Healthy Adult Volunteers

The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers.

The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone intramuscular (IM) injection.

Study Overview

• Status: Unknown
• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Intervention / Treatment: Drug: dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women aged 18 Years to 45 Years
• Must have a Body Mass Index (BMI) between 18 and 29 kg/m2, inclusive.
• Must, in the investigator's opinion, have no clinically significant disease as determined by medical and psychiatric history, physical examination, vital signs, and/or laboratory evaluations conducted at the screening visit or on clinic admission that would interfere with the evaluation of safety or pharmacokinetics.
• Must have negative screens for Hbs-Ag, HCV-Ab, and HIV-Ab, and no history of a positive result.
• Female subjects may be included if they are surgically sterile or 2 years post menopausal, and they have a negative serum pregnancy test at screening. Female subjects of child bearing potential and peri-menopausal subjects may be included if they have a negative serum pregnancy test at screening and on admission to the clinic on Day -1, and agree to use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial.
• Must be non-smokers, defined as not having smoked tobacco, used chewing tobacco, or used nicotine-containing products for smoking cessation in the 6 months prior to screening.
• Must be able to communicate effectively with the study personnel.
• Must agree to remain in the study facility overnight for approximately five consecutive days and nights.

Exclusion Criteria:

• Is a female subject who is pregnant, breastfeeding, or planning a pregnancy during the study.
• Has a clinically significant unstable medical abnormality, chronic disease, significant neurological (including seizure and cognitive disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease, or any other abnormality that could interfere with the PK evaluation of the study drug. Particular attention will be paid to exclude subjects with a risk for the consequences of systemic corticosteroid exposure, such as diabetes or poorly controlled hypertension.
• Has had a clinically significant illness within 30 days of Screening.
• Use of any prescription medication (other than hormonal contraceptives) within 14 days or over-the-counter (OTC) medication (with the exception of ibuprofen and acetaminophen) within 7 days of randomization or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug.
• Use of any topical creams, lotions or oils on the patch application site within 2 weeks of treatment administration in the first period and throughout the study.
• Use of any steroid, including topical steroid, within 4 weeks of treatment administration in the first period and throughout the study.
• Intake of grapefruit products, and foods, herbal products and over-the-counter or prescription medications that may interact with the CYP450 enzyme system from 7 days prior to treatment administration in the first period until completion of the end-of-study procedures.
• Has ingested alcohol within 24 hours before admission (Day -1) and throughout the study.
• Has a history of significant allergy or hypersensitivity to the study drugs or to any component of iontophoretic transdermal patch used in this study, including allergy or sensitivity to bandage adhesives or to sodium bisulfate.

• Has any of the following exclusionary clinical laboratory results:

  1. Hemoglobin less than 12.0 g/dL
  2. Serum creatinine greater than 2.0 mg/dL
  3. Abnormal liver function tests (serum glutamic oxaloacetic transaminase [SGOT], also called aspartate transaminase [AST]; or serum glutamic pyruvic transaminase [SGPT], also called alanine transaminase [ALT] more than twice the upper limit of normal)
  4. Elevated serum bilirubin more than 2 times the upper limit of normal
• Any blood donation or significant blood loss within 90 days of treatment administration in the first period.
• Any plasma donation within 7 days of randomization.
• Has any sensory dysfunction, any skin irritation, sensitivity or disease, or a tattoo that may in the opinion of the investigator interfere with assessment of topical effects at the site of patch application.
• Has history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.
• Has or develops a positive urine drug screen, including ethanol, cocaine, tetrahydrocannabinol, barbiturates, amphetamines, benzodiazepines, and opiates.
• Use of any other investigational drug within 30 days or five half-lives (whichever is longer) before treatment administration in the first period, or plans to use an investigational drug (other than the study drugs) during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; dexamethasone iontophoretic patch	Drug: dexamethasone; iontophoretic patch and injection
Active Comparator: 2; dexamethasone intramuscular injection	Drug: dexamethasone; iontophoretic patch and injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers.	0-33 hours
Pharmacokinetics and safety of dexamethasone iontophoretic patch	0-33 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone IM injection.	0-33 hours

Collaborators and Investigators

• Sponsor: Travanti Pharma Inc.
• Collaborators: Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): May 1, 2009
• Study Completion (Anticipated): May 1, 2009

Study Registration Dates

• First Submitted: May 6, 2009
• First Submitted That Met QC Criteria: May 6, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Estimate): May 7, 2009
• Last Update Submitted That Met QC Criteria: May 6, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2019 (Chief Medical Office (CMO) Alberta Health Services)