Expired Study
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Port Orange, Florida 32127


Purpose:

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.


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


Study is Available At:


Original ID:

CR9106341


NCT ID:

NCT00651534


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

An Open-label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:February 2008
Verification Date:April 2016
Last Changed Date:April 28, 2016
First Received Date:March 28, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Ronacaleret

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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