COPDPhase 1NCT01009424
A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
A Phase 1 study testing R7103 in people with COPD, run by Hoffmann-La Roche.
Trial summary
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- R7103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Dec 2009
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 40-70 years of age, inclusive.
- Body Mass Index 18-32 kg/m2, inclusive.
- Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
- Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).
Who cannot join
- Current smoker or history of smoking in the last three months.
- Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
- History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
- Exacerbation of COPD within 8 weeks before first dosing.
About this study
Official title: A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.
- Conditions
- COPD
- Being tested
- R7103
- 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.
R7103Drug
escalating inhaled dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1) Receives: Drug: R7103 |
| 2 | Experimental | R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2) Receives: Drug: R7103 |
| 3 | Experimental | R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3) Receives: Drug: R7103 |
| 4 | Experimental | R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4) Receives: Drug: R7103 |
| 5 | Experimental | R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5) Receives: Drug: R7103 |
| 6 | Experimental | R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6) Receives: Drug: R7103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
Measured: 18 days per arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009424
- Sponsor's protocol ID
- NP22131
- Status last verified
- Oct 2016
- First submitted
- 3 Nov 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01009424
- Acronym / sponsor ID
- NP22131
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Nov 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 assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: R7103R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1) |
| 2 | Experimental | Drug: R7103R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2) |
| 3 | Experimental | Drug: R7103R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3) |
| 4 | Experimental | Drug: R7103R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4) |
| 5 | Experimental | Drug: R7103R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5) |
| 6 | Experimental | Drug: R7103R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients 40-70 years of age, inclusive.
- Body Mass Index 18-32 kg/m2, inclusive.
- Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
- Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).
Key exclusion criteria (4 listed)
- Current smoker or history of smoking in the last three months.
- Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
- History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
- Exacerbation of COPD within 8 weeks before first dosing.
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 |
|---|---|---|
| R7103escalating inhaled dose | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
Time frame: 18 days per arm
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 27 Oct 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R7103 in people with COPD, run by Hoffmann-La Roche.
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 27 Oct 2016. 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?
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population (time frame: 18 days per arm). 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 27 Oct 2016.