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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00914433
• Other study ID #: TPI 1100-101
• Status: Withdrawn
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: November 30, 2012
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2012
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

Study was not initiated and terminated before start-up.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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,

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TPI 1100
1 dose only increasing dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway-specific and general safety and tolerability.		24 hours post-dose and on Day 4	Yes
Secondary	Effect on mRNA		24 hrs post-dose and on Day 4	No