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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: March 28, 2008
Last updated: April 28, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Drug: Ronacaleret
Phase 1

Study Type: Interventional
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.

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 32
Study Start Date: February 2008

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00651534

United States, Florida
GSK Investigational Site
Port Orange, Florida, United States, 32127
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00651534     History of Changes
Other Study ID Numbers: CR9106341
Study First Received: March 28, 2008
Last Updated: April 28, 2016

Keywords provided by GlaxoSmithKline:
Formulation Drug Study, healthy postmenopausal

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on April 28, 2017