Back to resultsSafety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
PTH134
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis, parathyroid hormone, pharmacodynamic, pharmacokinetic
Eligibility 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
Sites / Locations
- Novartis Investigative site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00676312
Brief Title
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Osteoporosis, parathyroid hormone, pharmacodynamic, pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cross-over treatment with increasing doses of PTH134, placebo and active comparator.
Intervention Type
Drug
Intervention Name(s)
PTH134
Other Intervention Name(s)
teriparatid
Primary Outcome Measure Information:
Title
•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 Measure Information:
Title
•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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG, Basel
Organizational Affiliation
Novartis Pharma AG, Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative site
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22289659
Citation
Hammerle 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.
Results Reference
derived
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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
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