Primary:*To assess the safety and tolerability of single ascending oral doses of GSK2239633 in healthy male subjects. Secondary*To assess the pharmacokinetics of GSK2239633 following single ascending oral doses in healthy male subjects. * To assess…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
*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.
Background summary
The drug to be given is a new investigational compound that may eventually be
used for the treatment of asthma and allergic bronchopulmonary aspergillosis.
It is a chemokine receptor 4 (CCR4) antagonist, a compound which is thought to
inactivate the part of the immune system that is involved in diseases like
asthma and allergic bronchopulmonary aspergillosis.
Study objective
Primary:
*To assess the safety and tolerability of single ascending oral doses of
GSK2239633 in healthy male subjects.
Secondary
*To assess the pharmacokinetics of GSK2239633 following single ascending oral
doses in healthy male subjects.
* To assess the relationship between pharmacokinetics and pharmacodynamics of
GSK2239633 following single ascending oral doses of GSK2239633 in healthy male
subjects.
* To assess the effect of food on the pharmacokinetics of GSK2239633 following
single oral doses of GSK2239633 in healthy male subjects.
Study design
This study will be performed in 24 healthy male subjects.
Group 1 will have 12 subjects, who will stay in the clinical research center
during 4 periods.
Group 2 will have 12 subjects, who will stay in the clinical research center
during 3 periods.
The study is planned for Group 1 to participate in 4 treatment periods
(including a food effect period), and Group 2 to participate in 3 treatment
periods (with no food effect period).
Study burden and risks
Procedures: pain, light bleeding, haematoma and possibly an infection
Stationsweg 163
9471 GP Zuidlaren
NL
Stationsweg 163
9471 GP Zuidlaren
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024085-22-NL |
| CCMO | NL36000.056.11 |