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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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01009424
Collaborator
(none)
0
Enrollment
6
Arms
2
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Oct 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2009
Anticipated Study Completion Date :
Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01009424
Other Study ID Numbers:
  • NP22131
First Posted:
Nov 6, 2009
Last Update Posted:
Oct 27, 2016
Last Verified:
Oct 1, 2016
Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Oct 27, 2016