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
1 other identifier
interventional
32
1 country
1
Brief Summary
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedDecember 11, 2008
December 1, 2008
3 months
May 8, 2008
December 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
•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 Outcomes (1)
•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.
Study Arms (1)
1
EXPERIMENTALCross-over treatment with increasing doses of PTH134, placebo and active comparator.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Investigative site
Basel, Switzerland
Related Publications (1)
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.
PMID: 22289659DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis Pharma AG, Basel
Novartis Pharma AG, Basel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 13, 2008
Study Start
May 1, 2008
Primary Completion
August 1, 2008
Last Updated
December 11, 2008
Record last verified: 2008-12