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

Roche

Status and phase: Withdrawn; Phase 1

Conditions: COPD

Treatments: Drug: R7103

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009424

NP22131

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 6 patient groups

1

Experimental group

Description:

R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1)

Treatment:

Drug: R7103

2

Experimental group

Description:

R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2)

Treatment:

Drug: R7103

3

Experimental group

Description:

R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3)

Treatment:

Drug: R7103

4

Experimental group

Description:

R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4)

Treatment:

Drug: R7103

5

Experimental group

Description:

R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5)

Treatment:

Drug: R7103

6

Experimental group

Description:

R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6)

Treatment:

Drug: R7103