CompletedPhase 1

Effects of Repeat Dosing of GSK1521498

United Kingdom49 participantsStarted 2009-09-22

Plain-language summary

The overall purpose of this study is to see whether the drug is safe and well tolerated when given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of people will be given the drug at variable strengths. The blood levels of the drug will be measured and the effects on mood and cognition (the mental processes involved in awareness, learning and judgement) will be assesed.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy as determined by a responsible and experienced physician * Non smoking male or female between 18 and 60 years of age inclusive * A female subject of child-bearing potential must use a contraception method listed in the protocol prior to the start of dosing until at least 14 days after receiving the last dose of study medication. * Male subjects must agree to use one of the contraception methods listed in the protocol from the first dose of study medication until at least 84 days after receiving the last dose of study medication. * BMI within the range 25 - 35 kg/m2 (inclusive). * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * QTcB or QTcF \< 450 msec. * Suitable for repeat cannulation. Exclusion Criteria: * Has clinically significant rhythm abnormalities identified during 24-hour screening Holter assessment. * Systolic blood pressure greater than 150 mmHg and/or diastolic BP greater than 90 mmHg. * Diabetes mellitus or physician-diagnosed dyslipidaemia requiring treatment * Self-administered Beck Depression Inventory II scale total score greater than 13 or suicide question score greater than zero at screening. * Positive pre-study drug/alcohol screen * Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening * Positive test for HIV antibody. * Pregnant or lactating females * Smoking history that…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability: adverse events, blood pressure, heart rate, ECG, clinical chemistry, heamatology, urinalysis, change in reaction times, change in mood scales

Timeframe: During 10 days of repeat dosing

Obtain benchmarking data on the cognitive and mood changes induced by a single dose of up to 10mg zolpidem

Timeframe: Single occasion

Trial details

NCT IDNCT00976105

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03-09

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