Status:
COMPLETED
Study in Healthy Volunteers, to Evaluate the Safety, Efficacy and Dose Responses of SB-751689 (Ronacaleret)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Transplantation, Stem Cell
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The present study aims to evaluate the impact of 5 days oral administration of ronacaleret 100 miligram (mg) and 400 mg on changes in circulating CD34+ cells, when ronacaleret is followed by the admin...
Eligibility Criteria
Inclusion
- A male or female between 18 and 65 years of age (inclusive).
- Healthy as determined by a physician, based on a medical evaluation and with an estimated Glomerular Filtration Rate (GFR) of \>=60 mL/min /1.73 m\^2 using the four variable Modification of Diet in Renal Disease (MDRD) equation.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5 x upper limit of normal (ULN) (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
- Female of non-child bearing potential, or female subjects and male subjects with female partners of child-bearing potential willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
- Body weight of 55 kg or more and body mass index (BMI) of 20.0 to 35.0 kg/m\^2 (inclusive).
- Capable of giving written informed consent.
Exclusion
- A positive pre-study drug/alcohol screen.
- A positive test for HIV, B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- History of or therapy for osteoporosis
- Subject has had treatment for any condition relating to the thyroid/parathyroid gland which in the opinion of the investigator may influence the subjects production of PTH
- Subjects with any contraindications or know allergies to receiving plerixafor
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- Subjects taking calcium and/or vitamin D supplements, during or within 2 weeks of study initiation
- Subjects taking any concomitant medications
- Specific laboratory abnormalities at screening like Serum calcium (total or albumin-adjusted) outside the central laboratory reference range, PTH outside the normal range, Creatine phosphokinase (CPK) outside the normal range
- Subjects with abnormal Vitamin D (Vitamin D, 25-Hydroxy) levels may be enroled if repeat lab results, obtained within 14 days of initial screening assessments, are within the normal range
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>14 drinks for males or \>7 drinks for females.
- Lactating or pregnant females as determined by positive serum human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- The subject has participated in a clinical trial within 30 days or 5 half-lives of the IP prior to the first dosing day in the current study.
- Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Key Trial Info
Start Date :
November 2 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01802892
Start Date
November 2 2012
End Date
April 2 2013
Last Update
June 7 2017
Active Locations (1)
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1
GSK Investigational Site
Overland Park, Kansas, United States, 66211