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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00676312
First received: May 8, 2008
Last updated: December 10, 2008
Last verified: December 2008

May 8, 2008
December 10, 2008
May 2008
August 2008   (final data collection date for primary outcome measure)
•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.
Same as current
Complete list of historical versions of study NCT00676312 on ClinicalTrials.gov Archive Site
•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.
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
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

This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Postmenopausal Osteoporosis
Drug: PTH134
Other Name: teriparatid
Experimental: 1
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
Intervention: Drug: PTH134
Hämmerle SP, Mindeholm L, Launonen A, Kiese B, Loeffler R, Harfst E, Azria M, Arnold M, John MR. The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women. Bone. 2012 Apr;50(4):965-73. doi: 10.1016/j.bone.2012.01.009. Epub 2012 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
August 2008   (final data collection date for primary outcome measure)

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

Female
40 Years to 70 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00676312
CPTH134A2101
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Pharma AG, Basel Novartis Pharma AG, Basel
Novartis
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP