To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females
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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.
An Open-label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy postmenopausal women
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
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