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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00651534
First received: March 28, 2008
Last updated: June 4, 2009
Last verified: May 2009
  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.


Condition Intervention
Healthy Volunteer
Postmenopausal
Drug: Ronacaleret

Study Type: Observational
Study Design: Time Perspective: Prospective
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
Intervention Details:
    Drug: Ronacaleret
    Other Name: Ronacaleret
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651534

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00651534     History of Changes
Other Study ID Numbers: CR9106341
Study First Received: March 28, 2008
Last Updated: June 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Formulation Drug Study, healthy postmenopausal

ClinicalTrials.gov processed this record on April 23, 2014