Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT01802892
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01802892
Study Brief:
Protocol Section:
NCT01802892