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WithdrawnNCT00914433Updated Dec 3, 2012

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

A Phase 1 interventional study of TPI 1100 in Chronic Obstructive Pulmonary Disease, sponsored by Syntara. Withdrawn. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-03.

Sponsored by Syntara · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Drug development suspended
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

Study was not initiated and terminated before start-up.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Syntara is the lead sponsor of 31 studies on the registry; none are open to participants now.

Browse Syntara studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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,
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    TPI 1100

    Drug to be given by inhalation.

    Drug: TPI 1100

Interventions

  • DrugTPI 1100

    1 dose only increasing dose

06

What researchers measure

Primary outcomes

  1. Airway-specific and general safety and tolerability.

    Time frame: 24 hours post-dose and on Day 4

Secondary outcomes

  1. Effect on mRNA

    Time frame: 24 hrs post-dose and on Day 4

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Dec 2009 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2009
First posted
Jun 5, 2009
Start
Apr 2009
Primary completionActual
Dec 2009
CompletionActual
Apr 2010
Last update
Dec 3, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00914433
Lead sponsor
Syntara
Responsible party
Sponsor
First posted
Jun 5, 2009
Start date
Apr 2009
Primary completion
Dec 2009
Completion
Apr 2010
Last update
Dec 3, 2012

Study contacts

Pageau
study director · Topigen Pharmaceuticals Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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