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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540878
• Other study ID #: CR9108307
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2007
• Last updated: May 15, 2009
• Start date: April 2007

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• SB-751689 oral tablets (400 mg)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Port Orange	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC and CMAX after a single dose.		after a single dose
Secondary	Safety and tolerability after single dose.		after a single dose