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This study has been withdrawn prior to enrollment.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,
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 September 22, 2014
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases