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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: SB-751689 oral tablets (400 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00540878

CR9108307

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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