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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

NCT ID: NCT01009424

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

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

Group Type EXPERIMENTAL

R7103

Intervention Type DRUG

escalating inhaled dose

2

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

Group Type EXPERIMENTAL

R7103

Intervention Type DRUG

escalating inhaled dose

3

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

Group Type EXPERIMENTAL

R7103

Intervention Type DRUG

escalating inhaled dose

4

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

Group Type EXPERIMENTAL

R7103

Intervention Type DRUG

escalating inhaled dose

5

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

Group Type EXPERIMENTAL

R7103

Intervention Type DRUG

escalating inhaled dose

6

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

Group Type EXPERIMENTAL

R7103

Intervention Type DRUG

escalating inhaled dose

Interventions

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R7103

escalating inhaled dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

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United States

Other Identifiers

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NP22131

Identifier Type: -

Identifier Source: org_study_id