Completed

A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

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What is being tested

Single IV dose of GSK2862277

+ Single IV dose of GSK2862277

+ Single IV dose of GSK2862277

Drug
Who is being recruted

Lung Diseases+3

+ Respiratory Tract Diseases

+ Thoracic Injuries

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: May 15, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: February 22, 2013

Actual date on which the first participant was enrolled.

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects. Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study. Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3. Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

NCT01818024
Principal SponsorGlaxoSmithKline
Last updated: May 15, 2017
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

54 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

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and InjuriesRespiration DisordersLung Injury

Criteria

7 inclusion criteria required to participate
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug/alcohol screen
A positive test for human immunodeficiency virus (HIV) antibody
Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Show More Criteria
4 exclusion criteria prevent from participating
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug/alcohol screen
A positive test for human immunodeficiency virus (HIV) antibody
Exposure to more than four new chemical entities within 12 months prior to the first dosing day

Study Plan

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

11 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single IV dose of GSK2862277 as a continuous infusion over 2 hours.

Group II

Experimental
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.

Group III

Experimental
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.

Group IV

Experimental
Single IV dose of GSK2862277 as a continuous infusion over 1 hour.

Group 5

Experimental
Matching placebo will be administered as a continuous IV infusion over 1 hour.

Group 6

Experimental
Single IH dose of GSK2862277.

Group 7

Experimental
Matching placebo will be administered.

Group 8

Experimental
IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days.

Group 9

Experimental
Matching placebo will be administered as IV infusion over 1 hour daily for 5 days.

Group 10

Experimental
Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days.

Group 11

Experimental
Matching placebo will be administered as IH daily for 5 days.

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

GSK Investigational Site

Harrow, United KingdomOpen GSK Investigational Site in Google Maps
CompletedOne Study Center