Ignite Creation Date:
2024-05-06 @ 12:00 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01466335
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2011-10-27
Brief Title:
An Adaptive Phase I Study to Evaluate the Safety Efficacy and Dose Responses of Ronacaleret in Healthy Human Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 PKPD 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 PKPD 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
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 PKPD 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 PKPD 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None