NL-OMON32631
Completed
N/A
A study to investigate the psychomotor and cognitive effects of alcohol when co-administered with GSK 1144814 or matching placebo in healthy subjects - GSK1144814 and ethanol interaction study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Alcoholverslaving
- Sponsor
- GlaxoSmithKline
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters significantly 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.
- •2\. Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- •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) and whose menopausal status is in doubt will be required to 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.
- •4\. 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 3 months after the last dose.
- •5\. Body weight \> 50 kg and BMI within the range 19 \- 29\.9 kg/m2 (inclusive).
- •6\. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •7\. Average QTcB or QTcF \< 450 msec.
- •8\. Demonstrates no evidence of mental impairment or co\-morbid psychiatric disorders
Exclusion Criteria
- •1\. A positive pre\-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •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\. History or presence of clinically significant cardiac arrhythmias, or other clinically significant cardiac disease.
- •4\. Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C\-SSRS in the last 6 months.
- •5\. Significant renal abnormality (from medical history or as indicated by laboratory investigations). Additionally subjects with idiopathic haematuria or proteinuria or conditions such as benign orthostatic proteinuria and benign familial haematuria should be excluded from the study)
- •6\. Subjects with LFT \>1\.5 ULN
- •7\. Subjects, who in the investigator's judgement, pose a significant homicidal risk or have ever been homicidal.
- •8\. A positive pre\-study drug/alcohol screen.
- •9\. A positive test for HIV antibody.
- •10\. History of regular alcohol consumption within 6 months of the study defined as:
Outcomes
Primary Outcomes
Not specified
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