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

NCT00803686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-06-09

Study results available
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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.

Conditions

  • Phase 1 Pharmacodynamic Study

Interventions

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.

Sponsors & Collaborators

  • Tarsa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Legg, D.O. · Bio-Kinetic Clinical Applications, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00803686 on ClinicalTrials.gov