A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
NCT ID: NCT01000818
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2008-06-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Period 1
MK0518
MK0518 (Raltegravir)
400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
Period 2
famotidine + MK0518
MK0518 (Raltegravir)
400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
famotidine
Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
Period 3
omeprazole + MK0518
MK0518 (Raltegravir)
400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
omeprazole
20 mg oral tablet of omeprazole, once daily for 5 days
Interventions
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MK0518 (Raltegravir)
400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
famotidine
Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
omeprazole
20 mg oral tablet of omeprazole, once daily for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is taking an MK0518 (Raltegravir) containing regimen
* Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
* Patient who is of reproductive potential agrees to use an acceptable method of birth control
* Patients baseline health is stable
Exclusion Criteria
* Patient has a history of gastric bypass surgery
* Patient is pregnant of breastfeeding
* Patient consumes excessive amounts of caffeinated beverages daily
* Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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MK0518-054
Identifier Type: -
Identifier Source: secondary_id
2009_681
Identifier Type: -
Identifier Source: secondary_id
0518-054
Identifier Type: -
Identifier Source: org_study_id
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