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WithdrawnNCT01009424Updated Oct 27, 2016

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

A Phase 1 interventional study of R7103 in COPD, sponsored by Hoffmann-La Roche. Withdrawn. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COPD
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

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

    Drug: R7103

  • Experimental
    2

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

    Drug: R7103

  • Experimental
    3

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

    Drug: R7103

  • Experimental
    4

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

    Drug: R7103

  • Experimental
    5

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

    Drug: R7103

  • Experimental
    6

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

    Drug: R7103

Interventions

  • DrugR7103

    escalating inhaled dose

06

What researchers measure

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

    Time frame: 18 days per arm

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01009424
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 6, 2009
Start date
Oct 2009
Primary completion
Dec 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Oct 27, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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