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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

TPI 1100

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPI 1100

Arm Description

Drug to be given by inhalation.

Outcomes

Primary Outcome Measures

Airway-specific and general safety and tolerability.

Secondary Outcome Measures

Effect on mRNA

Full Information

NCT ID

NCT00914433

First Posted

June 2, 2009

Last Updated

November 30, 2012

Sponsor

Pharmaxis

1. Study Identification

Unique Protocol Identification Number

NCT00914433

Brief Title

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

Official Title

A Phase 1,Randomized, Double--blind, Placebo-controlled Study Assessing the Safety and Tolerability, the Pharmacodynamics and Pharmacokinetics of Single-ascending and Repeated Doses of Inhaled TPI 1100 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Drug development suspended

Study Start Date

April 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmaxis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Study was not initiated and terminated before start-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TPI 1100

Arm Type

Experimental

Arm Description

Drug to be given by inhalation.

Intervention Type

Drug

Intervention Name(s)

TPI 1100

Intervention Description

1 dose only increasing dose

Primary Outcome Measure Information:

Title

Airway-specific and general safety and tolerability.

Time Frame

24 hours post-dose and on Day 4

Secondary Outcome Measure Information:

Title

Effect on mRNA

Time Frame

24 hrs post-dose and on Day 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pageau

Organizational Affiliation

Topigen Pharmaceuticals Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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