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

NCT ID: NCT00540878

Last Updated: 2009-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SB-751689 oral tablets (400 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy postmenopausal women; 40 and 65 years of age, inclusive

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials, M.D.

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Port Orange, Florida, United States

Countries

United States

Other Identifiers

CR9108307

Identifier Type: -

Identifier Source: org_study_id