Status:
COMPLETED
To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00651534
Start Date
February 1 2008
Last Update
May 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Port Orange, Florida, United States, 32127