Last updated: 11/04/2018 06:06:34
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
GW406381 pharmacokinetic parameters AUC and Cmax
Timeframe: throughout the study
Secondary outcomes:
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
Timeframe: throughout the study
Interventions:
Drug: GW406381
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain
Product
GW406381
Collaborators
Not applicable
Study date(s)
October 2005 to September 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
- Body weight less = 100 kg
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-26-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study CXA100754 can be found on the GSK Clinical Study Register.
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