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

This study has been withdrawn prior to enrollment.
(Drug development suspended)
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00914433
First received: June 2, 2009
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: TPI 1100
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • Airway-specific and general safety and tolerability. [ Time Frame: 24 hours post-dose and on Day 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect on mRNA [ Time Frame: 24 hrs post-dose and on Day 4 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPI 1100
Drug to be given by inhalation.
 Drug: TPI 1100
1 dose only increasing dose
Other Name: TPI 1100

Detailed Description:

Study was not initiated and terminated before start-up.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914433

Sponsors and Collaborators
Pharmaxis
Investigators
Study Director: Pageau Topigen Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00914433     History of Changes
Other Study ID Numbers: TPI 1100-101
Study First Received: June 2, 2009
Last Updated: November 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pharmaxis:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013