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

NCT00895076 | Unknown Phase 1

• 1 other identifier: 2019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

dexamethasone iontophoretic patch

Drug: dexamethasone

2

ACTIVE COMPARATOR

dexamethasone intramuscular injection

Drug: dexamethasone

Interventions

dexamethasone DRUG

iontophoretic patch and injection

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Hemoglobin less than 12.0 g/dL
• Serum creatinine greater than 2.0 mg/dL
• 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)
• 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.

Sponsors & Collaborators

• Travanti Pharma Inc.: lead
• Cetero Research, San Antonio: collaborator

Study Sites (1)

Cetero Research

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 7, 2009

Record last verified: 2009-05

Locations

US (1)