An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.

An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00423761

Enrollment

Registered

2007-01-18

Start date

2006-12-31

Completion date

Unknown

Last updated

2009-05-18

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

Conditions

Healthy Subjects

Keywords

Pharmacokinetics,, tolerability,, healthy,, subjects

Brief summary

This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.

Interventions

DRUGmidazolam

DRUGGW876008

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males or females. * Normal ECG. * Agree to remain in the clinic for the time defined in the protocol. * Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Exclusion criteria

* Any serious medical disorder or condition. * Any history of an endocrine disorder. * Any clinically significant laboratory abnormality. * History of psychiatric illness. * Any history of suicidal attempts or behavior. * Active peptic ulcer disease. * Positive faecal occult blood. * The subject smokes or has smoked or has used any nicotine-containing products in the last six months. * Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

Design outcomes

Primary

Measure	Time frame
Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.	on Day 1 of Session 1 and on Days 1 and 14 of Session 2.

Secondary

Measure	Time frame
12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2	day 1 session 1; days 1 & 14 session 2
vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2	day 1 session 1; days 1, 7 & 14 session 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026