Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

NCT00411125 — Phase 1, Completed, 86 participants, Novartis

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A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women

Registry	NCT00411125
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: double, treatment
Enrollment	86
Sponsor	Novartis (Industry)
Conditions	Postmenopausal Osteoporosis
Interventions	Oral salmon calcitonin (Drug)
Dates	start 2006-08-01, completion 2006-11-01, first posted 2006-12-13, last updated 2006-12-13
Locations	1 site in Denmark

-Summary

This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women

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+Arms and interventions

Oral salmon calcitonin (Drug)

+Outcome measures

Primary outcomes

Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Effect on bone resorption biomarker on Day 1

Secondary outcomes

Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
Effect on bone resorption biomarker after drug intake at different timepoints
Effect of dosing at different timepoints on the pharmacokinetic profile

+Eligibility

Sex: Female, ages: 40 Years to 70 Years

Inclusion Criteria:

* Healthy postmenopausal women

Exclusion Criteria:

* Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

+Locations (1)

Facility	City	Country	Status
	Copenhagen	Denmark

+Publications

Results publication: Karsdal MA, Byrjalsen I, Riis BJ, Christiansen C. Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin. BMC Clin Pharmacol. 2008 Dec 4;8:12. doi: 10.1186/1472-6904-8-12. PMID 19055791

+Investigators

Novartis Basel, Study director, Novartis Basel +41 61 324 1111