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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: SB-751689 oral tablets (400 mg)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Port Orange, Florida, United States, 32127
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, M.D., GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2007

Study Registration Dates

• First Submitted: October 4, 2007
• First Submitted That Met QC Criteria: October 4, 2007
• First Posted (Estimate): October 8, 2007

Study Record Updates

• Last Update Posted (Estimate): May 18, 2009
• Last Update Submitted That Met QC Criteria: May 15, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Formulation Drug Study
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: CR9108307