- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138072
A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.
November 4, 2010 updated by: GlaxoSmithKline
A Phase I, Single-center, Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.
This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin, and rosuvastatin in healthy adult subjects.
In this study, approximately 14 subjects will receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2248761.
Safety evaluations and serial PK samples will be collected during each treatment period.
A follow-up visit will occur 7-14 days after the last dose of study drug.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
Texas
-
Austin, Texas, United States, 78744
- GSK Investigational Site
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECGs.
- A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who: Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or is post-menopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone level will be performed to confirm a post-menopausal status. For this study, FSH levels > 40 MlU/ml is confirmatory.
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until the follow-up visit.
- Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion Criteria:
- As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- History of regular alcohol consumption within 6 months of the study.
- Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
- History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease.
- History/evidence of clinically significant pulmonary disease.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Note: this does not include plasma donation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
- Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
- Lactating females.
- The subject's systolic blood pressure is outside the range of 90-140 mmHg, or diastolic blood pressure is outside the range of 45-90 mmHg or heart rate is outside the range of 50-100 bpm for female subjects or 45-100 bpm for male subjects at Screening and predose Day 1.
- Cardiac conduction abnormalities denoted by any of the following on a single 12-lead ECG at screening or predose Day 1 (a single repeat is allowed for eligibility determination). Including evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome). Sinus Pauses > 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
Simvastatin 20mg (single dose) Day 1
|
20 mg Simvastatin single dose
|
Experimental: Treatment B
Atorvastain 20 mg (single dose) Day 3
|
20 mg atorvastatin single dose
|
Experimental: Treatment C
Rosuvastatin 10mg (single dose) Day 7
|
10 mg rosuvastatin single dose
|
Experimental: Treatment X
GSK2248761 200mg single dose Day 10-14, Day 16-17, Day 19-21, Day 23-24
|
200mg once daily
|
Experimental: Treatment D
GSK2248761 200mg + simvastatin 20 mg Day 15
|
20 mg Simvastatin single dose
200mg once daily
|
Experimental: Treatment E
GSK2248761 200mg + atorvastatin 20 mg Day 18
|
20 mg atorvastatin single dose
200mg once daily
|
Experimental: Treatment F
GSK2248761 200mg + rosuvastatin 20 mg Day 22
|
10 mg rosuvastatin single dose
200mg once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma simvastatin and simvastatin acid Cmax, AUC(0-infinity) and AUC(0-t) following oral administration of a single dose of simvastatin 20mg alone and in combination with GSK2248761 200mg once daily.
Time Frame: 18 days
|
18 days
|
Plasma atorvastatin Cmax, AUC(0-infinity) and AUC(0-t) following oral administration of a single dose of atorvastatin 20mg alone and in combination with GSK2248761 200mg once daily.
Time Frame: 21 days
|
21 days
|
Plasma rosuvastatin Cmax, AUC(0-∞) and AUC(0-t) following oral administration of a single dose of rosuvastatin 10mg alone and in combination with GSK2248761 200mg once daily.
Time Frame: 25 days
|
25 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma ortho and para-hydroxy atorvastatin Cmax, AUC(0-infinity) and AUC(0-t) following oral administration of a single dose of atorvastatin 20mg alone and in combination with GSK2248761 200mg once daily.
Time Frame: 21 days
|
21 days
|
Plasma simvastatin, simvastatin acid, atorvastatin, ortho and para-hydroxy atorvastatin, and rosuvastatin tmax, t1/2, and percent AUCex.
Time Frame: 25 days
|
25 days
|
Safety and tolerability parameters including adverse event, concurrent medication, clinical laboratory, ECG, and vital sign assessments.
Time Frame: 25 days
|
25 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
June 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
June 3, 2010
First Submitted That Met QC Criteria
June 3, 2010
First Posted (Estimate)
June 7, 2010
Study Record Updates
Last Update Posted (Estimate)
November 5, 2010
Last Update Submitted That Met QC Criteria
November 4, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- 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
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Rosuvastatin Calcium
- Simvastatin
Other Study ID Numbers
- 113818
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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