Healthy Subjects Clinical Trial
Official title:
An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects
NCT number | NCT00423761 |
Other study ID # | CRH103152 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | January 17, 2007 |
Last updated | May 15, 2009 |
Start date | December 2006 |
Verified date | May 2009 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.
Status | Completed |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 |
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