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A Study to Investigate Potential Interactions between GSK598809 and Ethanol in Healthy Subjects

Completed
Conditions
addiction
alcoholism
10037176
Registration Number
NL-OMON32561
Lead Sponsor
GlaxoSmithKline
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, psychiatric history, physical examination including mental status examination, laboratory tests and cardiac monitoring (12-lead ECG).
2. Male or female between 18 and 65 years of age.
3. 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) will not be included in the study.
* Child-bearing potential and agrees to use one of the contraception methods
listed in Section 8.1.1 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 90 days post final dose.
4. Male subjects must agree to use appropriate contraception methods (listed in Section 8.1.2. of the protocol). This criterion must be followed from the time of the first dose of study medication until 90 days post final dose.
5. Body weight ><= 50 kg and BMI within the range 18 * 30 kg/m2 (inclusive).
6. Occasional, non-daily smokers.
7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
8. QTcB or QTcF < 450 msec.

Exclusion Criteria

1. The subject has a positive pre-study drug/alcohol screen.
2. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
3. A history of or findings on evaluation consistent with any Axis I or Axis II disorder as defined in the DSM IV.
4. A positive test for HIV antibody.
5. History of regular alcohol consumption within 6 months of the study defined as:
an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
6. The subject has participated in a clinical trial and has received an investigational product within the 90 days prior to the first dosing day in the current study
7. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
8. 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.
9. History of sensitivity to any of the study medications, or components thereof or a history of drug or other clinically significant allergies.
10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
11. Pregnant females as determined by positive serum or urine beta-hCG test at screening and prior to dosing.
12. Lactating females or those who have lactated in last month.
13. Unwillingness or inability to follow the procedures outlined in the protocol.
14. History of sensitivity to heparin or heparin-induced trombocytopenia.
15. Subjects, who have asthma or a history of asthma, (e.g., for any FTIH where risk of bronchoconstriction is unknown, or compound specific where risk of bronchoconstriction).
16. Subjects who smoke on a daily basis.
17. 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.
18. Any subject who is not prepared to eat the standard meals provided by the clinic.
19. Liver function tests (LFT) that are above the laboratory reference range at screening and that remain elevated when repeated.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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