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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects

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ClinicalTrials.gov Identifier: NCT00676312
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : December 11, 2008
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: PTH134 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Partially-Blinded, Randomized, Placebo and Active Controlled, Ascending Single-Dose Crossover Phase I Study to Explore the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of PTH134 Formulated With Different Concentrations of 5-CNAC in Healthy Postmenopausal Women
Study Start Date : May 2008
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
 Drug: PTH134
Other Name: teriparatid


Outcome Measures
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Primary Outcome Measures :
  1. •Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours.

Secondary Outcome Measures :
  1. •Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours.

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Healthy postmenopausal female subjects, 40 to 70 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
  • Body mass index (BMI) within the range of 19 to 32.

Exclusion Criteria:

  • Smokers who report cigarette use of >= 5 cigarettes per day.
  • Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening.
  • Previous osteoporosis treatment
  • History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676312


Locations
Switzerland
Novartis Investigative site
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharma AG, Basel Novartis Pharma AG, Basel
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00676312     History of Changes
Other Study ID Numbers: CPTH134A2101
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008

Keywords provided by Novartis:
Osteoporosis
parathyroid hormone
pharmacodynamic
pharmacokinetic

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases