Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

Quick Stats
Studies 458
Trials 82
Terminated PHASE2 INTERVENTIONAL NCT01006616

Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-019)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Neutrophils are thought to play an important role in the pathophysiology of chronic obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil migration to the diseased lung. It is theorized that reducing neutrophil migration to the diseased lung will improve a participant's symptoms and the natural history of the disease. The study will consist of a 2-week screening period followed by a 2-year (104-week) double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a 26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1), followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants participating in the original 6-month study (Period 1) may elect not to continue into the 18-month extension study (Period 2). Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is discontinued, is superior to placebo with respect to improving airflow.

Interventions

Name: Navarixin
Type: DRUG
Description: Navarixin 10 mg and 30 mg capsules
Name: Placebo
Type: DRUG
Description: Placebo to navarixin capsules
Name: Rescue medication
Type: DRUG
Description: Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Primary Outcomes

Measure: Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)
TimeFrame: Baseline and Week 26
Description: FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline and Week 26.
Measure: Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L
TimeFrame: Up to 104 weeks
Description: The percentage of participants who experienced an AE related to an ANC of less than 1.5x10\^9 cells/L at one or more visits during the first 26 weeks, the first 52 weeks and the first 104 weeks was to be calculated.

Trial Information

NCT ID

NCT01006616

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Last Updated

December 15, 2025