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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00676312
Other study ID # CPTH134A2101
Secondary ID
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. completion date
Est. primary completion date August 2008
Accepts healthy volunteers
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


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.
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