A randomised, double-blind, placebo-controlled, cross-over study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending oral doses of GSK2239633 in healthy male subjects.
Completed
- Conditions
- Asthmafungal infection of the lungs10024970
- Registration Number
- NL-OMON36158
- Lead Sponsor
- PRA International EDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Male
18-65 years of age
BMI 18.5 - 29.9 kg/m2 (inclusive) and body weight >50 kg
Exclusion Criteria
Positive pre-study Hepatitis B, Hepatitis C, HIV
Diagnosed as not-healthy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events<br /><br>Clinically relevant changes in safety parameters: 12-lead ECG, telemetry, vital<br /><br>signs (systolic and diastolic blood pressure, heart rate, temperature),<br /><br>clinical laboratory data (haematology, clinical chemistry, urinalysis).</p><br>
- Secondary Outcome Measures
Name Time Method <p>*Derived pharmacokinetic parameters for GSK2239633 including area under the<br /><br>plasma drug concentration versus time curve (AUC(0-t), AUC(0-*)), maximum<br /><br>observed plasma drug concentration (Cmax), time to maximum observed plasma drug<br /><br>concentration (tmax), apparent clearance (CL/F) and terminal half-life (t1/2)<br /><br>following single oral doses.<br /><br>*Pharmacodynamic inhibitory effect of GSK2239633 on CCR4-mediated T cell actin<br /><br>polymerisation in whole blood.</p><br>