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
  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:


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):
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, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2014