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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

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

Details

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

Criteria

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