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

October 26, 2016 updated by: Hoffmann-La Roche

A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1)
Drug: R7103
escalating inhaled dose
EXPERIMENTAL: 2
R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2)
Drug: R7103
escalating inhaled dose
EXPERIMENTAL: 3
R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3)
Drug: R7103
escalating inhaled dose
EXPERIMENTAL: 4
R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4)
Drug: R7103
escalating inhaled dose
EXPERIMENTAL: 5
R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5)
Drug: R7103
escalating inhaled dose
EXPERIMENTAL: 6
R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6)
Drug: R7103
escalating inhaled dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 18 days per arm
18 days per arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (ESTIMATE)

November 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP22131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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