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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00676312
First received: May 8, 2008
Last updated: December 10, 2008
Last verified: December 2008
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Purpose
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
| Condition | Intervention | Phase |
|---|---|---|
| Postmenopausal Osteoporosis | Drug: PTH134 | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- •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:
- •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.
| Estimated Enrollment: | 32 |
| Study Start Date: | May 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
|
Drug: PTH134
Other Name: teriparatid
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00676312
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | May 8, 2008 |
| Last Updated: | December 10, 2008 |
Keywords provided by Novartis:
|
Osteoporosis parathyroid hormone pharmacodynamic pharmacokinetic |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on September 19, 2017