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This study has been withdrawn prior to enrollment.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
  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:


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 April 17, 2014