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

NCT ID: NCT00676312

Last Updated: 2008-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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

Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Keywords

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Osteoporosis parathyroid hormone pharmacodynamic pharmacokinetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

PTH134

Intervention Type DRUG

Interventions

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PTH134

Intervention Type DRUG

Other Intervention Names

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teriparatid

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharma AG, Basel

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharma AG, Basel

Locations

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Novartis Investigative site

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Hammerle SP, Mindeholm L, Launonen A, Kiese B, Loeffler R, Harfst E, Azria M, Arnold M, John MR. The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women. Bone. 2012 Apr;50(4):965-73. doi: 10.1016/j.bone.2012.01.009. Epub 2012 Jan 25.

Reference Type DERIVED
PMID: 22289659 (View on PubMed)

Other Identifiers

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CPTH134A2101

Identifier Type: -

Identifier Source: org_study_id