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

Novartis

Status and phase: Completed; Phase 1

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: PTH134

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676312

CPTH134A2101

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 1 patient group

1

Experimental group

Description:

Cross-over treatment with increasing doses of PTH134, placebo and active comparator.

Treatment:

Drug: PTH134