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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00540878
First received: October 4, 2007
Last updated: May 15, 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 Phase
Osteoporosis
Drug: SB-751689 oral tablets (400 mg)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC and CMAX after a single dose. [ Time Frame: after a single dose ]

Secondary Outcome Measures:
  • Safety and tolerability after single dose. [ Time Frame: after a single dose ]

Enrollment: 25
Study Start Date: April 2007
Intervention Details:
    Drug: SB-751689 oral tablets (400 mg)
    Other Name: SB-751689 oral tablets (400 mg)
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540878

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: NCT00540878     History of Changes
Other Study ID Numbers: CR9108307
Study First Received: October 4, 2007
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Formulation Drug Study

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014