Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers
This study has been withdrawn prior to enrollment.
(Drug development suspended)
Information provided by (Responsible Party):
First received: June 2, 2009
Last updated: November 30, 2012
Last verified: November 2012
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.
Chronic Obstructive Pulmonary Disease
Drug: TPI 1100
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
Experimental: TPI 1100
Drug to be given by inhalation.
Drug: TPI 1100
1 dose only increasing dose
Other Name: TPI 1100
Study was not initiated and terminated before start-up.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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,
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00914433
||Topigen Pharmaceuticals Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 2, 2009
||November 30, 2012
||Canada: Health Canada
Keywords provided by Pharmaxis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2015
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases