NCT00803686

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tarsa Therapeutics, Inc. · Industry
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Oral Placebo Tablet	Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
DRUG	Oral rsCT tablet	Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
DRUG	Fortical (rsCT) nasal spray	Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-12-05
• Last updated: 2014-06-09
• Results posted: 2014-06-09

Locations

1 site across 1 country: United States