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

NCT ID: NCT00803686

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-01-31

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.

Conditions

Phase 1 Pharmacodynamic Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part 1 Double Blind Oral rsCT Tablet

Intervention: Oral rsCT tablet given once 4 hours after evening meal.

Group Type: EXPERIMENTAL

Oral rsCT tablet

Intervention Type: DRUG

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

Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal

Group Type: PLACEBO_COMPARATOR

Oral Placebo Tablet

Intervention Type: DRUG

Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.

Part 2 Open label, Oral rsCT tablet

Intervention: Oral rsCT tablet given once 2 hours after evening meal.

Group Type: EXPERIMENTAL

Oral rsCT tablet

Intervention Type: DRUG

Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.

Part 2, Open Label Fortical Nasal Spray

Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal

Group Type: ACTIVE_COMPARATOR

Fortical (rsCT) nasal spray

Intervention Type: DRUG

Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

Interventions

Oral rsCT tablet

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.

Intervention Type: DRUG

Oral Placebo Tablet

Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.

Intervention Type: DRUG

Oral rsCT tablet

Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.

Intervention Type: DRUG

Fortical (rsCT) nasal spray

Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

Intervention Type: DRUG

Other Intervention Names

rsCT; Placebo; Fortical nasal spray

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tarsa Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Legg, D.O.

Role: PRINCIPAL_INVESTIGATOR

Bio-Kinetic Clinical Applications, Inc.

Locations

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, United States

Countries

United States

Other Identifiers

Bio-Kinetic No.: 13808

Identifier Type: OTHER

Identifier Source: secondary_id

UGL-OR0803

Identifier Type: -

Identifier Source: org_study_id