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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Healthy Volunteers
• Interventions: Drug: RV1162 single dose; Drug: RV1162 matching placebo single dose

• Registration Number: NCT01970618
• Lead Sponsor: Respivert Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: single dose escalation (healthy subjects)	RV1162 single dose	-
Part A: single dose escalation (healthy subjects)	RV1162 matching placebo single dose	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days,	Assessment of the number of adverse events reported by subject following dosing
ECG assessment (12-lead ECG)	Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days	Change from pre-dose values
Vital sign assessment (blood pressure and heart rate)	Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days	Change from pre-dose values
Spirometry assessment (FEV1 & FVC)	Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days	Change from pre-dose values
Clinical laboratory assessments (blood and urine samples)	Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days	Change from pre-dose values

Secondary Outcome Measures

Name	Time	Method
Plasma RV1162 levels	Part A: Cohorts 1 & 2 x 4 treatment periods (TP), Cohort 3 x 1 TP (0, 10, 15 & 30 min, 1 ,2, 4, 6, 8, 10, 12 & 24h post-dose) each TP; Part B (Cohort 4): 34 samples up to 21 days post-dose; Part C (Cohorts 5 & 6): 46 samples up to 28 days post-dose	Measurement of RV1162 in blood after dosing