Chronic Obstructive Pulmonary DiseasePhase 1NCT01197287
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study testing QAK423A in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
There are three elements to this study: Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned in healthy volunteers. Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of QAK423 are planned in COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- QAK423A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Feb 2005
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A:
- Healthy, male subjects aged 18-55 years of age able to provide written informed consent prior to study participation and determined as in good health by past medical history, physical examination, ECG, laboratory tests and urinalysis.
- Parts B and C:
- Male or female (post menopausal or surgically sterilized) patients with COPD, aged 40-75 years, with a smoking history of at least 10 pack years (i.e. smokers or ex-smokers).
- Diagnosis of mild or moderate COPD, according to the GOLD guidelines.
- Post-bronchodilator FEV1 at screening 50-80% of predicted.
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- No COPD exacerbations within the 3 months prior to dosing, no concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
- No medical conditions that may jeopardize the subjects participation in the study
- Weigh less than 100 kg
Who cannot join
- Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing.
- History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of QAK423 in Healthy Subjects and COPD Patients and Multiple, Titrated Dosing in COPD Patients
There are three elements to this study:
- Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned in healthy volunteers.
- Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of QAK423 are planned in COPD patients.
- Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.
Repeat dosing is planned in COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- QAK423A
- Keywords
- Chronic obstructive pulmonary disease
- 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.
QAK423ADrug
QAK423ADrug
QAK423ADrug
| Study group | Role | What they receive |
|---|---|---|
| QAK423A Arm A | Experimental | Not described Receives: Drug: QAK423A |
| QAK423A Arm B | Experimental | Not described Receives: Drug: QAK423A |
| QAK423A Arm C | Experimental | Not described Receives: Drug: QAK423A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD
Measured: 96 hours
Adverse events associated with repeat doses in mild to moderate COPD patients
Measured: 14 days
Secondary outcomes (1)
Pharmacokinetics of single and repeat doses of QAK423
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startMay 2004
- Primary completionFeb 2005
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197287
- Sponsor's protocol ID
- CQAK423A2101
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of QAK423 in Healthy Subjects and COPD Patients and Multiple, Titrated Dosing in COPD Patients
- ClinicalTrials.gov ID
- NCT01197287
- Acronym / sponsor ID
- CQAK423A2101
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Feb 2005 (actual)
- First posted
- 9 Sep 2010 (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.
There are three elements to this study:
- Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned in healthy volunteers.
- Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of QAK423 are planned in COPD patients.
- Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.
Repeat dosing is planned in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QAK423A Arm A | Experimental | Drug: QAK423A |
| QAK423A Arm B | Experimental | Drug: QAK423A |
| QAK423A Arm C | Experimental | Drug: QAK423A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, male subjects aged 18-55 years of age able to provide written informed consent prior to study participation and determined as in good health by past medical history, physical examination, ECG, laboratory tests and urinalysis.
- Male or female (post menopausal or surgically sterilized) patients with COPD, aged 40-75 years, with a smoking history of at least 10 pack years (i.e. smokers or ex-smokers).
- Diagnosis of mild or moderate COPD, according to the GOLD guidelines.
- Post-bronchodilator FEV1 at screening 50-80% of predicted.
- No COPD exacerbations within the 3 months prior to dosing, no concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
Key exclusion criteria (5 listed)
- Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing.
- History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| QAK423A | Drug | QAK423A Arm A |
| QAK423A | Drug | QAK423A Arm B |
| QAK423A | Drug | QAK423A Arm C |
Primary outcome
Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD
Time frame: 96 hours
Adverse events associated with repeat doses in mild to moderate COPD patients
Time frame: 14 days
1 secondary outcome
Pharmacokinetics of single and repeat doses of QAK423
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QAK423A in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 1 site in Germany.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD (time frame: 96 hours). The study lists 2 primary outcomes in all. 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 17 Sep 2010.