Completed

A Randomised, Double-blind, Placebo-controlled, Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV568 in Healthy Volunteers

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What is being tested

RV568 single dose

+ RV568 matching placebo single dose

+ RV568 repeat dose

Drug
Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 18 to 65 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorRespivert Ltd
Last updated: March 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

RV568 is being developed as a possible treatment of smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD). The main purpose of this study is to examine the safety and tolerability of a new inhaled formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and Part B. Part A (Cohorts 1, 2 & 3) will investigate 6 different dose levels of RV568 given as a single dose and Part B (Cohorts 4 & 5) will investigate 2 different dose levels of RV568 given once a day for 14 days.

NCT01661244
Principal SponsorRespivert Ltd
Last updated: March 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

10 inclusion criteria required to participate
Agree not to use over the counter (OTC) medications (including corticosteroids, decongestants, antihistamines, aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs)) and herbal medication (including, but not limited to, herbal tea and St. John's Wort), within 14 days before first administration of study medication and through to the final follow up visit, unless approved by the Investigator and Sponsor Medical Monitor. Occasional use of paracetamol at recommended doses ( <= 1 g/ 6 hours and <= 2 g/day) and continued pre-existing use of vitamins at recommended doses is allowed
Agree not to use prescription medications within 14 days before first administration of study medication and through the duration of the study (with the exception of contraception and hormone replacement therapy (HRT))
Average QTc(B) or QTc(F) < 450 msec (or QTc < 480 msec in healthy subjects with right bundle branch block)
Body weight >= 50 kg and body mass index within the range 19-29 kg/m2 (inclusive)
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21 exclusion criteria prevent from participating
A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening
A positive pregnancy test or is a lactating (nursing) female
A positive test for human immunodeficiency virus antibody
Allergy to any of the active or inactive ingredients in the study medication
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

London, United KingdomOpen in Google Maps
CompletedOne Study Center