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
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Osteoporosis||Drug: PTH134||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
Other Name: teriparatid
- •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.
- •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.
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
|Novartis Investigative site|
|Principal Investigator:||Novartis Pharma AG, Basel||Novartis Pharma AG, Basel|