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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers

NCT01762774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-05-09

No results posted yet for this study

Summary

This study is the First Time in Human Study for GSK2256294 and will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of GSK2256294 administered to healthy male volunteers (Cohort 1) and otherwise healthy adult male moderately obese smokers (Cohorts 2 to 4). Cohorts 1 and 2 will enrol 12 subjects each and each subject will take part in four study periods. All subjects will receive placebo regimen and three dosing regimens of GSK2256294 in a specified sequence (planned doses 2 mg, 6 mg and 18 mg in Cohort 1 and 15 mg, 40 mg and 100 mg in Cohort 2). Each study period will be followed by a Wash-out period of 7 to 14 days in Cohort 1 and up to 4 weeks in Cohort 2. During each study period subjects will be in-house from Day -1 until the 48 hours post dose assessments have been completed. Subjects will return to the unit as out-patients for remaining post-dose assessments. Subjects will then be followed for 7 to 14 days in Cohort 1 and up to 3 to 4 weeks in Cohort 2. Total duration of the study for Cohort 1 will be 98 days and for Cohort 2 it will be up to 144 days. Cohort 3 and 4 will each recruit 15 subjects. For Cohorts 3 and 4, each subject will take part in one treatment period of 18 days (Day-1 to Day 17) with dosing from Day 1 to Day 14. Subjects will then be followed for 7 to 14 days. Total duration of the study for Cohort 3 and Cohort 4 will be 67 days. Dose selection for Cohorts 3 and 4 will be based on the safety, PK profile and enzyme inhibition obtained in Cohorts 1 and 2. This study will also evaluate the evidence for a functional effect of soluble Epoxide Hydrolase (sEH) in a forearm blood flow (FBF) model.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK2256294

GSK2256294 capsules will be administered as once daily as single dose 2 mg, 6 mg, 15 mg in Cohort 1 and 15 mg, 40 mg, 100 mg in Cohort 2. GSK2256294 capsules will be administered once or twice daily (cohorts 3 and 4) at the dose determined from the data from Cohort 1 and 2. GSK2256294 capsules will be available in 1, 5, 25 mg dose strength.

DRUG

Placebo

Matching placebo will be administered once daily (cohorts 1 and 2); and once or twice daily (cohorts 3 and 4).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-16
Primary Completion
2014-05-01
Completion
2014-05-01

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 NCT01762774 on ClinicalTrials.gov