A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tarsa Therapeutics, Inc.
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Salmon calcitonin

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.