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

Purpose

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

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: PTH134	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

Further study details as provided by Novartis:

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.


Estimated Enrollment:	32
Study Start Date:	May 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Cross-over treatment with increasing doses of PTH134, placebo and active comparator.	Drug: PTH134 Other Name: teriparatid

Eligibility


Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676312

Locations


Switzerland
Novartis Investigative site
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis Pharma AG, Basel	Novartis Pharma AG, Basel

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00676312 History of Changes
Other Study ID Numbers:	CPTH134A2101
Study First Received:	May 8, 2008
Last Updated:	December 10, 2008
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:


Osteoporosis parathyroid hormone pharmacodynamic pharmacokinetic

Additional relevant MeSH terms:


Osteoporosis Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 27, 2015