- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01246804
The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER) (GINGER)
November 26, 2020 updated by: Radboud University Medical Center
The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the pharmacokinetics of a single dose of the UGT-substrate raltegravir.
Furthermore the safety profile of the combination is studied.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ginkgo biloba is an alternative medicine that is popular among HIV-infected patients because if its claimed positive effects on memory, concentration and depression.
Alternative medicine can cause drug-drug interactions with regular HIV-medication.
Raltegravir is a newly developed HIV integrase inhibitor.
It is metabolized in the liver by UGT1A1 and therefore its pharmacokinetic profile can be influenced by inhibitors or inducers of UGT1A1.
So far there are no data of the potential effect of ginkgo biloba on glucuronidation in vivo.
The current study is designed to evaluate the potential inductive effect of ginkgo biloba on the pharmacokinetics of raltegravir and the safety profile when used in combination.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nijmegen, Netherlands
- CRCN, Radboud University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is at least 18 and not older than 55 years at screening.
- 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:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ginkgo biloba + raltegravir
15 days ginkgo biloba 120mg BID + raltegravir 400mg SD
|
single dose 400mg raltegravir
Other Names:
15 days ginkgo biloba 120mg BID
Other Names:
|
Active Comparator: raltegravir
single dose raltegravir 400mg
|
single dose 400mg raltegravir
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
raltegravir concentrations
Time Frame: pharmacokinetic curve after a single dose of raltegravir alone or added to steady state ginkgo biloba
|
To determine the effect of chronic use of ginkgo biloba on the single-dose pharma-cokinetics (AUC0-inf, AUC0-12, Cmax, C12) of raltegravir 400mg in healthy volunteers.
|
pharmacokinetic curve after a single dose of raltegravir alone or added to steady state ginkgo biloba
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events
Time Frame: during entire study
|
To determine the safety of a single dose of raltegravir 400mg when combined with chronic use of ginkgo biloba.
|
during entire study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David M Burger, PharmD, PhD, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
November 22, 2010
First Submitted That Met QC Criteria
November 22, 2010
First Posted (Estimate)
November 23, 2010
Study Record Updates
Last Update Posted (Actual)
November 30, 2020
Last Update Submitted That Met QC Criteria
November 26, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neurocognitive Disorders
- Cognition Disorders
- HIV Infections
- Cognitive Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Raltegravir Potassium
Other Study ID Numbers
- UMCN-AKF 10.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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