Bone Marrow Transplantation Clinical Trial
Official title:
A Randomized, Double Blind, Parallel Group, Single Center, Adaptive Phase I Study to Evaluate the Safety, Efficacy and Dose Responses of SB-751689 (Ronacaleret; a Calcium Sensing Receptor Antagonist) for Durations Not to Exceed 28 Days, Versusplacebo in Healthy Human Volunteers.
Ronacaleret is an orally administered CaSR antagonist which has previously been demonstrated
to transiently increase PTH in both animals and humans. Additional studies in
post-menopausal women and patients with distal radial fractures have demonstrated both
anabolic and catabolic effects on bone biomarkers and scans of bone density. Based on
ronacalerets ability to interact with the CaSR inducing PTH release and activating
endogenous bone metabolism of both osteoblasts and osteoclasts, it is our intention to
evaluate the impact activation of this pathway has on mobilization of Hematopoietic stem
cell (HSCs) into the periphery.
This is an adaptive, phase I, randomized, single centre, double-blind dose finding,
parallel-group, multi-cohort placebo controlled study of the efficacy and safety of
ronacaleret in up to 45 healthy human volunteers. Cohorts of eligible subjects will be
studied for periods up to 28 days. Total daily doses of ronacaleret will range from 100mg,
up to 400mg and be administered for a maximum of 28days. The first part of this study will
evaluate several doses and schedules of ronacaleret, run in parallel, with respect to their
ability to affect mobilization of CD34+ cells into the peripheral circulation. In subsequent
cohorts of the study we will utilize information obtained from previous cohorts to further
refine and optimise those dosing paradigms which show efficacy. For the first cohort of
study participants; the study will commence with 6 days of dosing in an inpatient setting
followed by 21 days of continued dosing and evaluation as an outpatient, with a series of
regularly scheduled visits, with the final visit on day 28. The study period will include
evaluations of pharmacokinetic and pharmacodynamic parameters along with standard laboratory
and safety evaluations. The second cohort may be treated with ronacaleret for periods
ranging from 14 to 28 days in order to optimise the treatment paradigm with respect to
pharmacodynamic efficacy. The PK/PD of each group in cohort one will be utilized to make
adjustments in the total daily dose, dose frequency and or duration of dosing investigated
in cohort 2. Decisions will be made as to dropping doses based on the PK/PD results and any
safety considerations. An initial equal randomization amongst groups within the first cohort
may be adjusted to allow for other randomization strategies as various doses and schedules
are assessed.
The objective of this study is to characterise the dose-response curve for ronacaleret with
respect to safety and efficacy based on changes in peripheral CD34+ cell counts. Results
obtained from this study will inform us: of optimized doses, schedules, and durations of
treatment for future studies. Additional cohorts may be added to further explore the dose
schedule and duration if required. The exact number of cohorts studied will depend on the
results obtain from the prior groups and the desire to explore a variety of doses and
schedules. The aims of the present study (CR9115166) include an assessment of the
pharmacodynamic effects (mobilization of CD34+ cells), safety, tolerability, and
pharmacokinetics of ronacaleret in healthy human volunteers.
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