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.

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. - GSK2239633 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36158

Enrollment

Registered

2011-03-15

Start date

2011-04-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma fungal infection of the lungs

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male 18-65 years of age BMI 18.5 - 29.9 kg/m2 (inclusive) and body weight >50 kg

Exclusion criteria

Exclusion criteria: Positive pre-study Hepatitis B, Hepatitis C, HIV Diagnosed as not-healthy

Design outcomes

Primary

Measure	Time frame
Adverse events Clinically relevant changes in safety parameters: 12-lead ECG, telemetry, vital signs (systolic and diastolic blood pressure, heart rate, temperature), clinical laboratory data (haematology, clinical chemistry, urinalysis).	—

Secondary

Measure	Time frame
Derived pharmacokinetic parameters for GSK2239633 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-)), maximum observed plasma drug concentration (Cmax), time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half-life (t1/2) following single oral doses. *Pharmacodynamic inhibitory effect of GSK2239633 on CCR4-mediated T cell actin polymerisation in whole blood.	—

Measure

Time frame

*Derived pharmacokinetic parameters for GSK2239633 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-*)), maximum observed plasma drug concentration (Cmax), time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half-life (t1/2) following single oral doses. *Pharmacodynamic inhibitory effect of GSK2239633 on CCR4-mediated T cell actin polymerisation in whole blood.

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Countries

Netherlands

Outcome results