Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products

NCT03205605 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: HP-00070850
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is intended to determine the effect of heat and occlusion on oxybutynin products.

Conditions

Heat Effect

Outcome Measures

Primary Outcomes (5)

• PK Parameter

  Cmax (oxybutynin) during first heat period for patch (24-25.5 h)

  24 h, 24 h 15 min, 24 h 30 min, 24 h 45 min, 25 h, 25 h 15 min, 25 h 30 min post patch application

• PK Parameter

  Serum concentration (oxybutynin) at 30 h time point (patch removal)

  30 h post patch application

• PK Parameter

  Cmax (oxybutynin) at second heat exposure (30-31.5 h); after patch removed

  30 h, 30 h 15 min, 30 h 30 min (patch removed at 30 h)

• PK Parameter

  Cmax (oxybutynin)

  0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application

• PK Parameter

  Cmax (N-desethyl oxybutynin)

  0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application

Study Arms (4)

baseline patch

OTHER

patch

Drug: oxybutynin

baseline gel

OTHER

gel

Drug: oxybutynin

patch with heat

OTHER

patch

Drug: oxybutynin

gel with occlusion

OTHER

gel

Drug: oxybutynin

Interventions

oxybutynin DRUG

patch

baseline patch; patch with heat

Eligibility Criteria

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

You may qualify if:

• Men or non-pregnant, non-lactating women who are of any ethnic background between the age of 18 to 45 years old
• Subjects must be non-smokers/tobacco users (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
• Provide written informed consent before initiation of any of the study procedures
• Agree not to participate in another clinical trial/study or to participate in an investigational drug study for at least one month after the last study session
• Able to adhere to the study restrictions and protocol schedule
• Able to participate in all study sessions
• Subjects have upper arms large enough to allow for placement of 200 cm2 \[31 in2\] area for applications of gel. The arm distance from the greater tubercle to the olecranon process should be a minimum of 30 cm. The circumference of the upper arms should be a minimum of 30 cm.
• 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 (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
• Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
• Have normal screening laboratories for urine protein and urine glucose
• Female subjects must be of non-childbearing potential (as defined as surgically sterile \[i.e. history of hysterectomy or tubal ligation\] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure day, 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
• Agree not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day
• 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)
• Have normal vital signs:

You may not qualify if:

• Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of any study session
• Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
• Participation in any ongoing investigational drug trial/study or clinical drug trial/study
• History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
• Active positive Hepatitis B, C and/or HIV serologies
• Positive urine drug screening test
• Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medication (e.g. bisphosphonates \[to treat osteoporosis\], anticholinergics \[used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms\], antihistamines, topical corticosteroids) and short term (\<30 days) prescription medications during the period 0-3 days before a study session \[vitamin, herbal supplements and birth control medications not included)\]
• Donation or loss of greater than one pint of blood within 60 days of entry to the study
• Any prior allergies to oxybutynin, other ingredients in the patch, gel or oral tablet tested, to medical tape products or other skin patches
• Subject has problems with urinary retention, gastric retention or gastrointestinal obstruction
• Subject has ulcerative colitis
• Subject has gastric reflux disease or esophagitis
• Subject has uncontrolled narrow-angle glaucoma
• Subject has myasthenia gravis
• Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within one month before enrollment in this study or expects to receive an experimental agent during the study

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

General Clinical Research Center (GCRC) at the University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

oxybutynin

Results Point of Contact

• Title: Dr. Audra Stinchcomb
• Organization: University of Maryland, Baltimore School of Pharmacy

astinchc@rx.umaryland.edu

410-706-2646

Study Officials

• Audra L Stinchcomb, PhD

  University of Maryland Baltimore School of Pharmacy

  PRINCIPAL INVESTIGATOR

• Hazem E Hassan, PhD

  University of Maryland Baltimore School of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: January 2, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: April 11, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)