Osteoporosis
Conditions
Keywords
Formulation Drug Study, healthy postmenopausal
Brief summary
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.
Interventions
DRUGRonacaleret
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Countries
United States
Outcome results
None listed