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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)

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ClinicalTrials.gov Identifier: NCT01068145
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: SCH 527123 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Very low dose SCH 527123 Drug: SCH 527123
Very low dose SCH 527123, once daily for 7 days
Experimental: Low dose SCH 527123 Drug: SCH 527123
Low dose SCH 527123, once daily for 7 days
Experimental: Medium dose SCH 527123 Drug: SCH 527123
Medium dose SCH 527123, once daily for 7 days
Experimental: High dose SCH 527123 Drug: SCH 527123
High dose SCH 527123, once daily for 7 days
Placebo Comparator: Placebo to match SCH 527123 Drug: Placebo
Placebo capsules to match SCH 527123, once daily for 7 days
Experimental: Low dose SCH 527123 (Part 2) Drug: SCH 527123
Low dose capsule SCH 527123, once daily for 14 days
Experimental: Medium dose SCH 527123 (Part 2) Drug: SCH 527123
Medium dose capsule SCH 527123, once daily for 14 days
Experimental: High dose SCH 527123 (Part 2) Drug: SCH 527123
High dose capsule SCH 527123, once daily for 14 days
Placebo Comparator: Placebo (Part 2) Drug: Placebo
Placebo capsules to match SCH 527123, once daily for 14 days



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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).
  • 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).

Exclusion Criteria:

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.
  • 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.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01068145     History of Changes
Other Study ID Numbers: P05567
2008-006650-18 ( EudraCT Number )
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases