The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER)
NCT ID: NCT01246804
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2010-11-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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ginkgo biloba + raltegravir
15 days ginkgo biloba 120mg BID + raltegravir 400mg SD
raltegravir single dose
single dose 400mg raltegravir
ginkgo biloba multiple dose
15 days ginkgo biloba 120mg BID
raltegravir
single dose raltegravir 400mg
raltegravir single dose
single dose 400mg raltegravir
Interventions
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raltegravir single dose
single dose 400mg raltegravir
ginkgo biloba multiple dose
15 days ginkgo biloba 120mg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing
* Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to Day 1. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
* Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Exclusion Criteria
* Positive HIV test.
* Positive hepatitis B or C test.
* Pregnant female (as confirmed by an HCG test performed less than 4 weeks before Day 1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the trial.
* Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
* Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to Day 1.
* Donation of blood within 60 days prior to Day 1.
* Febrile illness within 3 days before Day 1.
18 Years
55 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David M Burger, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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CRCN, Radboud University Medical Centre
Nijmegen, , Netherlands
Countries
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Related Links
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Publication of results of the study
Other Identifiers
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UMCN-AKF 10.02
Identifier Type: -
Identifier Source: org_study_id