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

Novartis32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postmenopausal Osteoporosis

Interventions

PTH134DRUG

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative site

Basel, Switzerland

Outcomes

Primary Outcomes

•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 Outcomes

•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.

Data from ClinicalTrials.gov

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