A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
Overview
- Phase
- Phase 2
- Intervention
- Oral rsCT tablet
- Conditions
- Phase 1 Pharmacodynamic Study
- Sponsor
- Tarsa Therapeutics, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Pharmacodynamic Effect of Oral Calcitonin
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.
Detailed Description
Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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 a Non-Steroidal Anti-inflammatory Drug (NSAID).
- •History of surgery within 60 days of enrollment.
- •History of hypersensitivity or allergies (other than seasonal allergies) within -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, SERMS, estrogen or estrogen-like drugs 2 months, or calcitonin 1 month.
- •Presence of any clinically significant illness.
Arms & Interventions
Part 1 Double Blind Oral rsCT Tablet
Intervention: Oral rsCT tablet given once 4 hours after evening meal.
Intervention: Oral rsCT tablet
Part 1, Double-blind Oral Placebo Tablet
Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal
Intervention: Oral Placebo Tablet
Part 2 Open label, Oral rsCT tablet
Intervention: Oral rsCT tablet given once 2 hours after evening meal.
Intervention: Oral rsCT tablet
Part 2, Open Label Fortical Nasal Spray
Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal
Intervention: Fortical (rsCT) nasal spray
Outcomes
Primary Outcomes
Pharmacodynamic Effect of Oral Calcitonin
Time Frame: 12 hr
C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc
Secondary Outcomes
- Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women(12 hours)
- AUCInhibition=Hours*%P(12 Hours)