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

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ClinicalTrials.gov Identifier: NCT00914433
Recruitment Status : Withdrawn (Drug development suspended)
First Posted : June 5, 2009
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: TPI 1100 Phase 1

Detailed Description:
Study was not initiated and terminated before start-up.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2009
Primary Completion Date : December 2009
Study Completion Date : April 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: TPI 1100
Drug to be given by inhalation.
Drug: TPI 1100
1 dose only increasing dose

Outcome Measures

Primary Outcome Measures :
  1. Airway-specific and general safety and tolerability. [ Time Frame: 24 hours post-dose and on Day 4 ]

Secondary Outcome Measures :
  1. Effect on mRNA [ Time Frame: 24 hrs post-dose and on Day 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914433

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

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00914433     History of Changes
Other Study ID Numbers: TPI 1100-101
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by Pharmaxis:

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