A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

Pain Clinical Trial

Official title:

An Open-label, Non-randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373243
• Other study ID #: CXA100754
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2006
• Last updated: September 7, 2017
• Start date: October 19, 2005
• Est. completion date: September 26, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 26, 2006
• Est. primary completion date: September 26, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases
• Pain

Intervention

Drug:
• GW406381
GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.

Locations

Country	Name	City	State
Hungary	GSK Investigational Site	Balantonfured
Hungary	GSK Investigational Site	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GW406381 pharmacokinetic parameters AUC and Cmax		throughout the study
Secondary	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

External Links

•   Results for study CXA100754 can be found on the GSK Clinical Study Register.