A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy Women

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400mg SB-751689 (a Calcium-Sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: SB-751689 oral tablets (400 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy postmenopausal women; 40 and 65 years of age, inclusive Non-smokers (as defined in exclusion criteria 6 below) 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 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 A QTc interval of > 450 msec at screening 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB-751689 oral tablets (400 mg)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC and CMAX after a single dose. |  | after a single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability after single dose. |  | after a single dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Formulation Drug Study