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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676312
• Other study ID #: CPTH134A2101
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2008
• Last updated: December 10, 2008
• Start date: May 2008

Study information

• Verified date: December 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2008
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• PTH134

Locations

Country	Name	City	State
Switzerland	Novartis Investigative site	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•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	•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.