To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females

NCT ID: NCT00651534

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

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

Interventions

Ronacaleret

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy postmenopausal women
• Non-smokers
• 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
• QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
• Hispanic or non-Hispanic (Caucasian) ethnicity

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
• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Port Orange, Florida, United States

Countries

United States

Other Identifiers

CR9106341

Identifier Type: -

Identifier Source: org_study_id