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

Phase 1

Withdrawn

• Conditions: COPD
• Interventions: Drug: R7103

• Registration Number: NCT01009424
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	R7103	R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2)
3	R7103	R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3)
4	R7103	R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4)
5	R7103	R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5)
1	R7103	R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1)
6	R7103	R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6)

Primary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population	18 days per arm