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

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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. The target sample size is approximately 30 individuals.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.