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

This study has been suspended.

( Need to review design )

First Received: June 2, 2009 Last Updated: June 3, 2009 History of Changes

Sponsored by:	Topigen Pharmaceuticals
Information provided by:	Topigen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00914433

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Topigen Pharmaceuticals:

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 ]

Estimated Enrollment:	36
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TPI 1100: Experimental	Drug: TPI 1100 1 dose only increasing dose

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

Topigen Pharmaceuticals

Investigators

Study Director:

Pageau

Topigen Pharmaceuticals Inc.

More Information

No publications provided

Responsible Party:	Topigen Pharmaceuticals Inc. ( Senior Director, Clinical Research )
Study ID Numbers:	TPI 1100-101
Study First Received:	June 2, 2009
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00914433 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Topigen Pharmaceuticals:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Healthy
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 03, 2009