Last updated: 11/04/2018 06:03:51
An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.
GSK study ID
CRH103152
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label, single-sequence study to evaluate the potential CYP 3A4 pharmacokinetic interaction of GW876008 in healthy subjects
Trial description: This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
Timeframe: on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
Secondary outcomes:
12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2
Timeframe: day 1 session 1; days 1 & 14 session 2
vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2
Timeframe: day 1 session 1; days 1, 7 & 14 session 2
Interventions:
Drug: midazolam
Drug: GW876008
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
emicerfont, midazolam
Collaborators
Not applicable
Study date(s)
December 2006 to February 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- Healthy males or females.
- Normal ECG.
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-16-02
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
Additional information
Not applicable
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