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

COPD Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01009424
• Other study ID #: NP22131
• Status: Withdrawn
• Phase: Phase 1
• First received: November 3, 2009
• Last updated: October 26, 2016
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• R7103
escalating inhaled dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No