A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
Condition: Phase 1 Pharmacodynamic Study
Intervention: Oral rsCT tablet; Oral Placebo Tablet; Oral rsCT tablet; Fortical (rsCT) nasal spray
Intervention description: On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.; Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.; Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.; Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
Intervention MeSH terms: Salmon calcitonin; Calcitonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria

          -  Postmenopausal female, in good health (at least five years since last menses).

          -  Age greater than or equal to 45 years old and less than or equal to 70 years old

          -  Weight ± 20% of the Metropolitan Life weight table.

          -  Plasma CTx-1 greater than or equal to 0.25 ng/ml.

          -  Total calcium, phosphorus, and magnesium 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, 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 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.

          -  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.