A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects
NCT ID: NCT01114607
Last Updated: 2017-07-18
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
24 participants
INTERVENTIONAL
2010-05-05
2010-06-29
Brief Summary
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Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.
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Detailed Description
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All subjects will receive single 500mg doses of the following five GSK1605786 formulations: A. ChemoCentryx formulation of GSK1605786; 2 x 250mg capsules \[Formulation A\] B. GSK formulation of GSK1605786; 2 x 250mg capsules \[Formulation B\] C. GSK direct-fill formulation of GSK1605786; 2 x 250mg capsules \[Formulation C\] D. GSK modified formulation of GSK1605786; 2 x 250mg capsules \[Formulation D\] E. GSK tablet formulation of GSK1605786; 500mg tablet \[Formulation E\]
Formulations A and B will administered in periods 1 and 2 in a random order, and formulations C, D and E will be administered in periods 3, 4, and 5 in a random order.
Subjects will check into the clinical research unit (CRU) 1 day prior to dosing (Day -1). The study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes after a standard breakfast (i.e., fed state). For each treatment period, subjects will stay in the CRU through the 48-hour PK sample on the morning of Day 3. Subjects may be released from the clinic on Day 3 (after all required study procedures are completed) and return to the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples.
Upon completion of the last dosing period or early withdrawal, subjects will return to the clinic approximately seven days after the last dose of study medication for a follow up visit and be subsequently discharged from the study.
The study will be conducted at one center.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Treatment sequence ABCDE
Eligible subjects will be randomized in sequence ABCDE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence ABDEC
Eligible subjects will be randomized in sequence ABDEC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence ABECD
Eligible subjects will be randomized in sequence ABECD and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence ABCED
Eligible subjects will be randomized in sequence ABCED and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= a film coated tablet of GSK1605786 GSK formulation 500 mg once daily and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence ABDCE
Eligible subjects will be randomized in sequence ABDCE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence ABEDC
Eligible subjects will be randomized in sequence ABEDC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence BACDE
Eligible subjects will be randomized in sequence BACDE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence BADEC
Eligible subjects will be randomized in sequence BADEC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence BAECD
Eligible subjects will be randomized in sequence BAECD and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence BACED
Eligible subjects will be randomized in sequence BACED and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence BADCE
Eligible subjects will be randomized in sequence BADCE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Treatment sequence BAEDC
Eligible subjects will be randomized in sequence BAEDC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Interventions
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GSK1605786 ChemoCentryx: formulation A
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation B
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation C
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation D
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation E
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Eligibility Criteria
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Inclusion Criteria
2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. 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.
3. Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
4. A female subject is eligible to participate if she is of:
* Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
* Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 4 weeks post-last dose.
5. 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 4 weeks post-last dose.
6. Body weight ≥ 50 kg (110lbs) for men and ≥45 kg (99 lbs) for women, and BMI within the range 18.5 - 31 kg/m2 (inclusive).
7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
8. 12-lead ECG without any clinically significant abnormality as judged by the Investigator, and average QTcB or QTcF \< 450 msec or QTc \< 480 msec in subjects with Bundle Branch Block.
9. Able to complete all study procedures and planned treatment periods.
Exclusion Criteria
2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
3. Known celiac disease and positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)
4. A positive pre-study drug/alcohol screen.
5. A positive test for HIV antibody.
6. History of regular alcohol consumption within 6 months of the study defined as:
• an average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
7. Unwilling to abstain from alcohol for 48 hours prior to screening, and 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
8. 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).
9. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
10. 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.
11. History of sensitivity to the study medication, 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.
12. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
13. Pregnant females as determined by positive serum hCG test at screening or urine hCG test prior to dosing.
14. Lactating females.
15. The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg, or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects at Screening and pre-dose on Day 1.
16. Unwillingness or inability to follow the procedures outlined in the protocol.
17. Subject is mentally or legally incapacitated.
18. Subject with a medical condition which in the opinion of the investigator and GSK Medical Monitor makes them unsuitable for the study.
19. History of sensitivity to heparin or heparin-induced thrombocytopenia.
20. History of regular use of tobacco- or nicotine-containing products within 6 months prior to screening and unwilling to remain abstinent from tobacco or nicotine containing products for the duration of the study.
21. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pomegranate, and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
18 Years
55 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Buffalo, New York, United States
Countries
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Other Identifiers
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114203
Identifier Type: -
Identifier Source: org_study_id
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