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

NCT01970618 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-11-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Respivert Ltd

    lead INDUSTRY

Principal Investigators

  • Jerome Boscia, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970618 on ClinicalTrials.gov