NCT01970618

Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients

A Randomised, Double Blind, Placebo-controlled, Three Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1162 in Healthy Subjects and Subjects With Chronic Obstructive Pulmonary Disease.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Respivert Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

RV1162 is a new medicine being developed for possible treatment of smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of RV1162.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RV1162 single dose	Safety and tolerability of single escalating doses
DRUG	RV1162 matching placebo single dose	Safety and tolerability of single escalating doses
DRUG	RV1162: 7 day repeat dose	Safety and tolerability of a repeat dose
DRUG	RV1162 matching placebo: 7 day repeat dose	Safety and tolerability of a repeat dose
DRUG	RV1162: 14 day repeat dose	Safety and tolerability of repeat escalating doses
DRUG	RV1162 matching placebo: 14 day repeat dose	Safety and tolerability of repeat escalating doses

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-10-28
• Last updated: 2014-11-20

Locations

1 site across 1 country: United Kingdom