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

NCT01009424 | Withdrawn Phase 1

• 1 other identifier: NP22131
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (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

Study Arms (6)

1

EXPERIMENTAL

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

Drug: R7103

2

EXPERIMENTAL

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

Drug: R7103

3

EXPERIMENTAL

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

Drug: R7103

4

EXPERIMENTAL

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

Drug: R7103

5

EXPERIMENTAL

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

Drug: R7103

6

EXPERIMENTAL

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

Drug: R7103

Interventions

R7103 DRUG

escalating inhaled dose

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 6, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 27, 2016

Record last verified: 2016-10