Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01802892
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2012-11-01
Brief Title:
Study in Healthy Volunteers to Evaluate the Safety Efficacy and Dose Responses of SB-751689 Ronacaleret
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Label Single Center Adaptive Phase I Study in Healthy Volunteers to Evaluate the Safety Efficacy and Dose Responses of SB-751689 Ronacaleret a Calcium Sensing Receptor Antagonist
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:
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 administration of a single dose of plerixafor in healthy human volunteers
This single centre adaptive design study will be carried out in 2 parts The part A will evaluate the change in peripheral circulating CD34 cells in response to two different 5 day regimens of ronacaleret 100 mg or 400 mg once daily given in conjunction with a single dose of plerixafor 024 mgkilogram kg sub-cutaneously SC on the evening of the final days dosing approximately 12 hours before collection of CD34 cells on day 6 Subjects 5 each will be assigned to either one of the ronacaleret arms in an open fashion Comparisons will be made in the change from baseline to end of treatment peripheral CD34 cell counts Part A will be conducted in two cohorts with 5 subjects being enrolled into each of the 2 treatment arms making up the first cohort Cohort 2 will involve up to 5 further subjects being enrolled into each treatment arm
The structure of part B will be finalized following a review of data generated in part A
The total study duration of Part A for each subject including the screening treatment and follow-up periods will be approximately 7 weeks
This single centre adaptive design study will be carried out in 2 parts The part A will evaluate the change in peripheral circulating CD34 cells in response to two different 5 day regimens of ronacaleret 100 mg or 400 mg once daily given in conjunction with a single dose of plerixafor 024 mgkilogram kg sub-cutaneously SC on the evening of the final days dosing approximately 12 hours before collection of CD34 cells on day 6 Subjects 5 each will be assigned to either one of the ronacaleret arms in an open fashion Comparisons will be made in the change from baseline to end of treatment peripheral CD34 cell counts Part A will be conducted in two cohorts with 5 subjects being enrolled into each of the 2 treatment arms making up the first cohort Cohort 2 will involve up to 5 further subjects being enrolled into each treatment arm
The structure of part B will be finalized following a review of data generated in part A
The total study duration of Part A for each subject including the screening treatment and follow-up periods will be approximately 7 weeks
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