Clareo Health | Study to Evaluate the Safety and Dose-Range of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (MK-7123-012)
Study to Evaluate the Safety and Dose-Range of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (MK-7123-012)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
41–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of COPD based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria.
\>40 to \<=75 years of age, of either sex, and of any race.
Current smoker with at least 10 pack-years of smoking history (eg, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years). Participant will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment. Participant who elects to continue to smoke will be eligible for enrollment. Once enrolled, if a participant elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study.
History of daily sputum production for at least the past 3 months.
Post-bronchodilator FEV1 must be \>=800 mL, and \>=40% to \<=70% of predicted FEV1.
Post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) must be \<=70%.
Female participants of childbearing potential must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate less than 1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy.
Female participants should be encouraged to continue using a highly effective method of birth control 30 days following the end of treatment.
Female participant of child-bearing potential who is not currently sexually active must agree to use a highly effective method of contraception should she become sexually active while participating in the study.
Male participant must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women using a highly effective birth control method according to the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95 mod).
A highly effective method of birth control is defined as that which results in a low failure rate (ie, less that 1% per year) when used consistently and correctly, such as hormonal implants, injectables, combined oral contraceptives, hormonal IUDs.
Female participant who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal.
Capable of complying with the dosing regimen and visit schedules.
Willing to give written informed consent to participate in the study.
You may not be if
Diagnosed with asthma or other clinically relevant lung disease (other than COPD), eg, sarcoidosis, tuberculosis, pulmonary fibrosis, bronchiectasis, or lung cancer.
History of previous lung surgery (eg, lobectomy, pneumonectomy, or lung volume reduction).
Lower respiratory tract infection within 4 weeks prior to the Screening Visit.
Receiving chronic antibiotic therapy.
Exacerbation of COPD within the 4 weeks prior to the Screening Visit.
\>20% change at Screening in post-bronchodilator FEV1.
Female participant who is breast-feeding, pregnant, or intends to become pregnant during the study.
Clinically relevant medical conditions (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic).
Taken inhaled or systemic steroids within 4 weeks of Screening Visit (Visit 1).
Received an investigational drug within the last 30 days.
Produced an inadequate amount of sputum at the Screening Visit (Visit 1) or is known to have difficulty producing sputum.
PBN count of \<3000 cells/microliters at Screening Visit (Visit 1).
Part of the staff personnel directly involved with this study.
Family member of the investigational study staff.
Received any study prohibited medication more recently than the indicated washout period, prior to (Screening), or who must continue to receive any prohibited treatment.
