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

Lateral Epicondylitis (Tennis Elbow) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00895076
• Other study ID #: 2019
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 6, 2009
• Last updated: May 6, 2009
• Start date: May 2009
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Travanti Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis (Tennis Elbow)
• Tennis Elbow

Intervention

Drug:
• dexamethasone
iontophoretic patch and injection

Locations

Country	Name	City	State
United States	Cetero Research	Fargo	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Travanti Pharma Inc.	Cetero Research, San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Pharmacokinetics and safety of dexamethasone iontophoretic patch		0-33 hours	Yes
Secondary	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	Yes