Pain
Conditions
Keywords
hepatic impairment pharmacokinetics
Brief summary
This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.
Interventions
DRUGGW406381
GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9 * Body weight less = 100 kg * Body mass index (BMI) within range of 19 - 32 32kg/m2
Exclusion criteria
* Presence of any other significant disease * Use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and GSK personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GW406381 pharmacokinetic parameters AUC and Cmax | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG | throughout the study |
Countries
Hungary
Outcome results
None listed