Chronic Obstructive Pulmonary DiseasePhase 1NCT00914433
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers
A Phase 1 study testing TPI 1100 in people with Chronic Obstructive Pulmonary Disease, run by Syntara.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TPI 1100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
About this study
Official title: 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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TPI 1100
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI 1100Drug
1 dose only increasing dose
| Study group | Role | What they receive |
|---|---|---|
| TPI 1100 | Experimental | Drug to be given by inhalation. Receives: Drug: TPI 1100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway-specific and general safety and tolerability.
Measured: 24 hours post-dose and on Day 4
Secondary outcomes (1)
Effect on mRNA
Measured: 24 hrs post-dose and on Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionApr 2010
Why it stopped: Drug development suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pageau, Study director, Topigen Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914433
- Sponsor's protocol ID
- TPI 1100-101
- Status last verified
- Nov 2012
- First submitted
- 2 Jun 2009
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00914433
- Acronym / sponsor ID
- TPI 1100-101
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug development suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPI 1100 | Experimental | Drug: TPI 1100Drug to be given by inhalation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPI 11001 dose only increasing dose | Drug | TPI 1100 |
Primary outcome
Airway-specific and general safety and tolerability.
Time frame: 24 hours post-dose and on Day 4
1 secondary outcome
Effect on mRNA
Time frame: 24 hrs post-dose and on Day 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pageau study director
Topigen Pharmaceuticals Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPI 1100 in people with Chronic Obstructive Pulmonary Disease, run by Syntara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway-specific and general safety and tolerability. (time frame: 24 hours post-dose and on Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.