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Port Orange, Florida 32127


This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.


Inclusion criteria: - Healthy postmenopausal women - Non-smokers - Body weight > or = 50 kg and BMI within the range 19-32 kg/m2 - Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form - QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block - Hispanic or non-Hispanic (Caucasian) ethnicity Exclusion criteria: - Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study - Positive urine drug screen at screening - Positive urine test for alcohol at pre-dose - Positive for HIV or hepatitis B or C virus at screening - Urinary cotinine levels indicative of smoking at screening - History of smoking or use of nicotine containing products within one year of the study or >10 pack-year history of smoking overall - History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening - History of drug abuse within 6 months of the study - Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Use of prescription or non-prescription drugs - Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication - Donation of blood in excess of 500 mL within 56 days prior to dosing - Evidence of renal, hepatic or biliary impairment - History of serious gastrointestinal disease - History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. - History of clinically significant cardiovascular disease - Medical conditions that might alter bone metabolism - Serum parathyroid hormone (iPTH) test levels outside the reference range at screening - Liver function tests, parathyroid hormone test or CPK outside the reference range at screening



Primary Contact:

Study Director
GSK Clinical Trials

Backup Contact:


Location Contact:

Port Orange, Florida 32127
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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