Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers (NCT00488449) | Clinical Trial Compass
CompletedPhase 1
Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers
United States56 participantsStarted 2007-06
Plain-language summary
The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.
Who can participate
Age range
18 Years – 55 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 Adult males or females between 18 and 55 years of age, inclusive.
* Female subjects must be of non-childbearing potential
* Body weight \> 50 kg (110 pounds) and body mass index (BMI) 19 and 31 where:
* Subjects with QTc \< 450 msec at screening (or QTc \< 480 msec for subjects with Bundle Branch Block).
* A signed and dated written informed consent prior to admission to the study.
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restriction
Exclusion criteria:
* Systolic blood pressure \< 100 mmHg or 150 mmHg and/or diastolic blood pressure = 100 mmHg at screening.
* History of significant cardiac arrhythmias
* Active peptic ulcer disease (PUD) and/or history of PUD within 1 year.
* A serum uric acid concentration 8mg/dL
* Screening test positive for H. Pylori using the non-radioactive breath test
* History of gout and/or hyperuricemia
* History of Gilbert's syndrome
* A serum creatinine concentration above the normal reference range
* History of kidney stones
* PT and/or aPTT above the reference range
* History of recurrent indigestion, stomach upset or diarrhea
* Liver function tests (LFTs) or creatinine phosphokinase (CPK) 1.5X ULN
* Screening stool test positive for occult blood
* Screening peripheral blood smear with abnormal RBCs
* CBC, MCV, and/or reticulocyte count corrected for haemoglobin level above the reference range at screening
* Reduced G6PD activity
* Serum haptoglobi…
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.