Chronic Obstructive Pulmonary DiseasePhase 1NCT01068145
Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and Chronic Obstructive Pulmonary Disease (COPD) Patients (P05567 AM7)
A Phase 1 study testing SCH 527123 in people with Chronic Obstructive Pulmonary Disease, run by Merck Sharp & Dohme LLC.
Trial summary
Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- SCH 527123
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Mar 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1
- Subject of either sex and of any race between the age of 18 and 55 years, with a BMI (weight [kg]/height [m2]) between 19 and 32.
- Subject must have a FEV1 ≥ 80 % of predicted value.
- Subject must be nonsmoker (including cigarettes, cigars and pipes) or exsmoker who has stopped smoking for at least 6 months (smoking history ≤ 5 pack years).
- Subject's clinical laboratory tests (CBC, blood chemistry, urinalysis) must be within normal limits. Subjects must have a neutrophil count of >2.0 x 109/L. (also Part 2)
- Subject must be free of any clinically significant disease that would interfere with the study evaluations (also Part 2).
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- Screening ECG conduction intervals must be within gender specific normal range; QTcB males ≤430 msec and females ≤450 msec (also Part 2).
- Vital sign measurements must be: a) oral body temperature, between 35.0°C and 37.5°C; b) systolic blood pressure, 90 to 140 mm Hg (160 mm Hg, Part 2); c) diastolic blood pressure, 45 to 90 mm Hg (100 mm Hg, Part 2); d) pulse rate, 40 to 100 bpm.
- Subject and partner(s) must be using an accepted method of contraception during the trial through 2 months post-treatment (also Part 2).
- Prior to randomization, subject must be a responder to ozone (also Part 2).
- Part 2
- Subject with a diagnosis of COPD for at least 1 year and FEV1 ≥65% of predicted value post bronchodilation (measurement 30 minutes after 400 mcg salbutamol administration) and FEV1/FVC of <70%.
- Subject of either sex and of any race between the age of 40 and 65 years, with a BMI between 19 and 32.
- Subject must be active or exsmoker (cigarettes, cigars and/or pipes).
- Subject must have a normal exercise stress test (no clinically significant ECG findings).
Who cannot join
- Part 1 and Part 2
- Female subject who is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding.
- Subject with history of seasonal or perennial allergic rhinitis (ie, season for specific allergen).
- Subject who has an allergy or a contraindication to excipients in placebo or SCH 527123 formulations or salbutamol.
- Surgical or medical condition (history or presence) which might alter the ADME of the drug: a) inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; b) major gastrointestinal tract surgery, ie, gastrectomy, gastroenterostomy, or bowel resection; c) pancreatic injury or pancreatitis; d) liver disease or injury; e) impaired renal function indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or f) urinary obstruction or difficulty in voiding.
- Subject who has any infectious disease within 4 weeks prior to drug administration.
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- Subject who is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
- Subject who has a positive screen for drugs with a high potential for abuse (Screening and/or treatment period).
- Subjects with a history of mental instability or who have been treated for mood disorder.
- Subject with a history of alcohol or drug abuse in the past 2 years.
- Subject who has donated blood in the past 60 days.
- Subject who has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which may interfere with ability to participate in the trial.
- Subject who has previously received SCH 527123 (Part 2 only)
- Subject who has received any of the following treatments more recently than indicated washout period prior to Baseline:
- Parts 1 and 2: OTC medications (excluding paracetamol), 14 days.
- Part 1: prescription medications, 14 days; investigational drugs, 30 days.
- Part 2: vitamins and herbal supplements, 14 days; statins, 4 weeks; steroids (inhaled), 4 weeks; steroids (oral and dermal), 8 weeks; antibiotics, 6 weeks; leukotriene antagonists, 4 weeks; NSAIDS, 2 weeks.
About this study
Official title: Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled, Incomplete Crossover, Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and COPD Patients
Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- SCH 527123, Placebo
- 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.
SCH 527123Drug
Very low dose SCH 527123, once daily for 7 days
SCH 527123Drug
Low dose SCH 527123, once daily for 7 days
SCH 527123Drug
Medium dose SCH 527123, once daily for 7 days
SCH 527123Drug
High dose SCH 527123, once daily for 7 days
PlaceboDrug
Placebo capsules to match SCH 527123, once daily for 7 days
SCH 527123Drug
Low dose capsule SCH 527123, once daily for 14 days
SCH 527123Drug
Medium dose capsule SCH 527123, once daily for 14 days
SCH 527123Drug
High dose capsule SCH 527123, once daily for 14 days
PlaceboDrug
Placebo capsules to match SCH 527123, once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Very low dose SCH 527123 | Experimental | Not described Receives: Drug: SCH 527123 |
| Low dose SCH 527123 | Experimental | Not described Receives: Drug: SCH 527123 |
| Medium dose SCH 527123 | Experimental | Not described Receives: Drug: SCH 527123 |
| High dose SCH 527123 | Experimental | Not described Receives: Drug: SCH 527123 |
| Placebo to match SCH 527123 | Placebo comparator | Not described Receives: Drug: Placebo |
| Low dose SCH 527123 (Part 2) | Experimental | Not described Receives: Drug: SCH 527123 |
| Medium dose SCH 527123 (Part 2) | Experimental | Not described Receives: Drug: SCH 527123 |
| High dose SCH 527123 (Part 2) | Experimental | Not described Receives: Drug: SCH 527123 |
| Placebo (Part 2) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD/PK: Dose response of SCH 527123 on ozone-induced sputum neutrophilia in healthy subjects (Part 1) and subjects with COPD (Part 2), measured by placebo-adjusted percent change in sputum neutrophil counts and absolute sputum neutrophil counts.
Measured: Part 1, four treatment periods, Part 2 three treatment periods duration of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068145
- Sponsor's protocol ID
- P05567
- Other IDs
- 2008-006650-18, 2008
- Status last verified
- Mar 2015
- First submitted
- 11 Feb 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Holz O, Khalilieh S, Ludwig-Sengpiel A, Watz H, Stryszak P, Soni P, Tsai M, Sadeh J, Magnussen H. SCH527123, a novel CXCR2 antagonist, inhibits ozone-induced neutrophilia in healthy subjects. Eur Respir J. 2010 Mar;35(3):564-70. doi: 10.1183/09031936.00048509. Epub 2009 Jul 30.
PubMed 19643947
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled, Incomplete Crossover, Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and COPD Patients
- ClinicalTrials.gov ID
- NCT01068145
- Acronym / sponsor ID
- P05567
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Feb 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.
Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Very low dose SCH 527123 | Experimental | Drug: SCH 527123 |
| Low dose SCH 527123 | Experimental | Drug: SCH 527123 |
| Medium dose SCH 527123 | Experimental | Drug: SCH 527123 |
| High dose SCH 527123 | Experimental | Drug: SCH 527123 |
| Placebo to match SCH 527123 | Placebo comparator | Drug: Placebo |
| Low dose SCH 527123 (Part 2) | Experimental | Drug: SCH 527123 |
| Medium dose SCH 527123 (Part 2) | Experimental | Drug: SCH 527123 |
| High dose SCH 527123 (Part 2) | Experimental | Drug: SCH 527123 |
| Placebo (Part 2) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Part 1
- Subject of either sex and of any race between the age of 18 and 55 years, with a BMI (weight [kg]/height [m2]) between 19 and 32.
- Subject must have a FEV1 ≥ 80 % of predicted value.
- Subject must be nonsmoker (including cigarettes, cigars and pipes) or exsmoker who has stopped smoking for at least 6 months (smoking history ≤ 5 pack years).
- Subject's clinical laboratory tests (CBC, blood chemistry, urinalysis) must be within normal limits. Subjects must have a neutrophil count of >2.0 x 109/L. (also Part 2)
Key exclusion criteria (17 listed)
- Part 1 and Part 2
- Female subject who is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding.
- Subject with history of seasonal or perennial allergic rhinitis (ie, season for specific allergen).
- Subject who has an allergy or a contraindication to excipients in placebo or SCH 527123 formulations or salbutamol.
- Surgical or medical condition (history or presence) which might alter the ADME of the drug: a) inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; b) major gastrointestinal tract surgery, ie, gastrectomy, gastroenterostomy, or bowel resection; c) pancreatic injury or pancreatitis; d) liver disease or injury; e) impaired renal function indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or f) urinary obstruction or difficulty in voiding.
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 |
|---|---|---|
| SCH 527123Very low dose SCH 527123, once daily for 7 days | Drug | Very low dose SCH 527123 |
| SCH 527123Low dose SCH 527123, once daily for 7 days | Drug | Low dose SCH 527123 |
| SCH 527123Medium dose SCH 527123, once daily for 7 days | Drug | Medium dose SCH 527123 |
| SCH 527123High dose SCH 527123, once daily for 7 days | Drug | High dose SCH 527123 |
| PlaceboPlacebo capsules to match SCH 527123, once daily for 7 days | Drug | Placebo to match SCH 527123 |
| SCH 527123Low dose capsule SCH 527123, once daily for 14 days | Drug | Low dose SCH 527123 (Part 2) |
| SCH 527123Medium dose capsule SCH 527123, once daily for 14 days | Drug | Medium dose SCH 527123 (Part 2) |
| SCH 527123High dose capsule SCH 527123, once daily for 14 days | Drug | High dose SCH 527123 (Part 2) |
| PlaceboPlacebo capsules to match SCH 527123, once daily for 14 days | Drug | Placebo (Part 2) |
Primary outcome
PD/PK: Dose response of SCH 527123 on ozone-induced sputum neutrophilia in healthy subjects (Part 1) and subjects with COPD (Part 2), measured by placebo-adjusted percent change in sputum neutrophil counts and absolute sputum neutrophil counts.
Time frame: Part 1, four treatment periods, Part 2 three treatment periods duration of the trial.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Results publication: PubMed 19643947Holz O, Khalilieh S, Ludwig-Sengpiel A, Watz H, Stryszak P, Soni P, Tsai M, Sadeh J, Magnussen H. SCH527123, a novel CXCR2 antagonist, inhibits ozone-induced neutrophilia in healthy subjects. Eur Respir J. 2010 Mar;35(3):564-70. doi: 10.1183/09031936.00048509. Epub 2009 Jul 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCH 527123 in people with Chronic Obstructive Pulmonary Disease, run by Merck Sharp & Dohme LLC.
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 15 inclusion and 17 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: stopped early, as of the sponsor's last update on 26 Mar 2015. 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. Some participants in this study may receive a placebo. 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 stopped early. Results are not available in the source record.
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?
PD/PK: Dose response of SCH 527123 on ozone-induced sputum neutrophilia in healthy subjects (Part 1) and subjects with COPD (Part 2), measured by placebo-adjusted percent change in sputum neutrophil counts and absolute sputum neutrophil counts. (time frame: Part 1, four treatment periods, Part 2 three treatment periods duration of the trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068145, which also lists 1 linked publication.
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 26 Mar 2015.