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Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers

NCT ID: NCT00914433

Last Updated: 2012-12-03

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-04-30

Brief Summary

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This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D \& 7A in blood and in sputum.

Detailed Description

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Study was not initiated and terminated before start-up.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TPI 1100

Drug to be given by inhalation.

Group Type EXPERIMENTAL

TPI 1100

Intervention Type DRUG

1 dose only increasing dose

Interventions

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TPI 1100

1 dose only increasing dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, male or female volunteers aged 18 to 55 years inclusive
* Screening/baseline FEV1 greater than 90% predicted,
* Body mass index (BMI) of 19 to 28 inclusive,
* Clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the Investigator

Exclusion Criteria

* Airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems,
* Breast-feeding or pregnancy,
* Positive tests for smoking tobacco, alcohol, hepatitis B-surface antigen, hepatitis C antibody, and HIV at screening,
* History of serious adverse reaction to any drugs,
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syntara

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pageau

Role: STUDY_DIRECTOR

Topigen Pharmaceuticals Inc.

Other Identifiers

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TPI 1100-101

Identifier Type: -

Identifier Source: org_study_id