A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

Study Overview
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Brief Summary
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This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Recombinant Salmon Calcitonin (rsCT)
* Drug: Oral Tablet
* Drug: Oral Tablet
* Drug: Nasal Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal female, in good health (at least 5 years since last menses) Age ≥45 and ≤70 Weight + or - 20% of the Metropolitan Life weight table Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range Willing and able to comply with all study requirements Willing and able to sign written informed consent Negative urine pregnancy test at screening Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse Exclusion Criteria: History of parathyroid, thyroid, pituitary or adrenal diseases History of musculoskeletal disease History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders History of cancer within 5 years of enrollment other than basal cell carcinoma History of regular use of non-steroidal anti-inflammatory drugs (NSAID) History of surgery within 60 days of enrollment History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month Presence of any clinically significant illness Unwilling or unable to comply with all study requirements Unwilling or unable to sign written, informed consent History of drug or alcohol abuse Participation in any clinical study of an investigational drug within 60 days of enrollment Plasma CTx-1 less than 0.25 ng/mL

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rsCTA<br>Oral Tablet | Drug: Oral Tablet<br>* 0.15 mgs recombinant salmon calcitonin, single oral dose<br>|
| Experimental: rsCTB<br>Oral Tablet | Drug: Oral Tablet<br>* 0.2mgs recombinant salmon calcitonin, single oral tablet<br>|
| Active Comparator: Fortical<br>Nasal Spray | Drug: Recombinant Salmon Calcitonin (rsCT)<br>* Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.<br>* Other names: Fortical® nasal spray;Drug: Nasal Spray<br>* 200 IU recombinant salmon calcitonin, single intranasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) | This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray. | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB |