A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women
Overview
- Phase
- Phase 1
- Intervention
- LY333334
- Conditions
- Osteoporosis, Postmenopausal
- Sponsor
- Eli Lilly and Company
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Part A - Cumulative Skin Irritation by Draize Score
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized, placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy postmenopausal women. Part A will examine the cumulative irritation and adherence of the transdermal patch, and Part B will examine skin sensitization and adherence. Two separate groups of subjects will be enrolled for Part A and Part B of the study. All screening procedures will take place up to 28 days prior to enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Are overtly healthy postmenopausal females, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests (for example, subjects who have osteoporosis or stable and/or controlled hyperlipidemia, hypertension, and/or hypothyroidism may be entered if that investigator judges it appropriate for participation in this study).
- •Postmenopausal women include women with at least 6-weeks postsurgical bilateral oophorectomy with or without hysterectomy, confirmed by medical history, or spontaneous amenorrhea for at least 6 to 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (eg, oral contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) and a follicle-stimulating hormone level greater than 40 mIU/mL.
- •Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- •Have a sitting blood pressure and pulse rate that are judged to be not clinically significant by the investigator.
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- •Have given written informed consent approved by Eli Lilly and Company (Lilly) and the ethical review board (ERB) governing the site.
Exclusion Criteria
- •Are currently enrolled in, or discontinued within the last 3 months from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have known hypersensitivity to teriparatide or to any of its excipients.
- •Are persons who have previously completed or withdrawn from this study or any other study investigating teriparatide patch.
- •Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
- •Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
- •Show evidence of hepatitis C and/or positive hepatitis C antibody.
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
- •Have a history of breast cancer within the past 10 years or other types of carcinoma within the past 5 years, except for excised superficial skin tumors and adequately treated in situ carcinoma of cervix.
Arms & Interventions
LY333334 + placebo
Part A: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days Part B: Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks Rest phase: 2 weeks with no patch application Challenge phase: 80 microgram active patch given once for at least 6 hours
Intervention: LY333334
LY333334 + placebo
Part A: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days Part B: Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks Rest phase: 2 weeks with no patch application Challenge phase: 80 microgram active patch given once for at least 6 hours
Intervention: Placebo
Outcomes
Primary Outcomes
Part A - Cumulative Skin Irritation by Draize Score
Time Frame: Day 1 through Day 22
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter \[mm\]).
Part B - Skin Irritation and Sensitization by Draize Score
Time Frame: Days 1 - 19 and 34 - 37
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).
Secondary Outcomes
- Part A - Patch Adhesion Score(Day 1 through Day 22)
- Part B - Patch Adhesion Score(Days 1 - 19 and 34 - 37)