Last updated: 11/04/2018 06:01:40
To estimate relative bioavailability of 5 formulations of ronacaleret given to healthy postmenopausal females
GSK study ID
CR9106341
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Ronacaleret
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoporosis
Product
ronacaleret
Collaborators
Not applicable
Study date(s)
February 2008 to April 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
Yes
- Healthy postmenopausal women
- Non-smokers
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Port Orange, Florida, United States, 32127
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-06-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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