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

Phase 1

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: TPI 1100

• Registration Number: NCT00914433
• Lead Sponsor: Syntara

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.

Detailed Description

Study was not initiated and terminated before start-up.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-05
• Primary Completion: 2009-12
• Study Completion: 2010-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TPI 1100	TPI 1100	Drug to be given by inhalation.

Primary Outcome Measures

Name	Time	Method
Airway-specific and general safety and tolerability.	24 hours post-dose and on Day 4

Secondary Outcome Measures

Name	Time	Method
Effect on mRNA	24 hrs post-dose and on Day 4