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A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

NCT01818024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-05-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Single IV dose of GSK2862277

GSK2862277 solution available in a 40 mg vial for IV administration.

DRUG

Matching placebo single dose IV infusion

Matching placebo solution available for IV administration.

DRUG

Single IH dose of GSK2862277

GSK2862277 nebulised solution available in a 40 mg vial for IH administration.

DRUG

Matching placebo single dose IH

Matching placebo nebulised solution available for IH administration.

DRUG

Repeat IV dose of GSK2862277

GSK2862277 solution available in a 40 mg vial for IV administration.

DRUG

Matching placebo repeat dose IV infusion

Matching placebo solution available for IV administration.

DRUG

Repeat IH dose selected of GSK2862277 from Part 2

GSK2862277 nebulised solution available in a 40 mg vial for IH administration.

DRUG

Matching placebo repeat dose IH

Matching placebo nebulised solution available for IH administration.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-22
Primary Completion
2013-10-25
Completion
2013-10-25

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 NCT01818024 on ClinicalTrials.gov