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Trial record 33 of 109 for:    CALCIUM CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00676312
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : December 11, 2008
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE May 8, 2008
First Posted Date  ICMJE May 13, 2008
Last Update Posted Date December 11, 2008
Study Start Date  ICMJE May 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2008)
•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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00676312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2008)
•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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Official Title  ICMJE 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
Brief Summary This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE Drug: PTH134
Other Name: teriparatid
Study Arms  ICMJE Experimental: 1
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
Intervention: Drug: PTH134
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)
32
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676312
Other Study ID Numbers  ICMJE CPTH134A2101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Novartis Pharma AG, Basel Novartis Pharma AG, Basel
PRS Account Novartis
Verification Date December 2008

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