A Second Study to Determine the Effect of GSK256073A on HVTs (NCT00551694) | Clinical Trial Compass
CompletedPhase 1
A Second Study to Determine the Effect of GSK256073A on HVTs
United States4 participantsStarted 2007-10
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 that have been administrated GSK256073 in the HMA107787 study
Who can participate
Age range18 Years – 55 Years
SexALL
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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 physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring. 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 considers that the finding will not introduce additional risk factors and will not interfere with the study procedures
* Healthy adult males or females between 18 and 55 years of age, inclusive.
* Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy, or documented hysterectomy - tubal ligation is not sufficient
* Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 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 restrictions
Exclusion Criteria:
* Any clinically relevant abnormality identified on the screening medical assessment, laboratory …
What they're measuring
1
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing throughout the study.
Timeframe: throughout the study.
2
AUC and Cmax
Timeframe: throughout the study
3
Measures of accumulation ratios throughout the study (Ro, Rp, and Rs)[Period 2]