Safety, Tolerability, Pharmacodynamics and Pharmacokineti... | NCT00914433

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

NCT00914433

Sponsor

Syntara

Status

Withdrawn

Last Update Posted

Dec 3, 2012Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

TPI 1100

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drug development suspended

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TPI 1100	Experimental	Drug to be given by inhalation.	Drug: TPI 1100

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TPI 1100	Drug	1 dose only increasing dose	TPI 1100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Airway-specific and general safety and tolerability.		24 hours post-dose and on Day 4

Secondary Outcomes

Measure	Description	Time Frame
Effect on mRNA		24 hrs post-dose and on Day 4

Other Outcomes

Not provided

Eligibility Module

Eligibility 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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pageau	Topigen Pharmaceuticals Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided