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NCT01802892 · ClinicalTrials.gov registry record · Phase 1
Study in Healthy Volunteers, to Evaluate the Safety, Efficacy and Dose Responses of SB-751689 (Ronacaleret)
A Phase 1 study of Transplantation, Stem Cell, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01802892: Completed Phase 1 study of Transplantation, Stem Cell, sponsored by GlaxoSmithKline.
NCT01802892 is a Phase 1 study of Transplantation, Stem Cell that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802892, a Phase 1 study of Transplantation, Stem Cell, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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 (0.24 mg/kilogram \[kg\]) 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.
Primary Outcome
The mean fold change from baseline in the number of circulating CD34+ cells for all treatment arms will be assessed. Samples will be collected at screening, Day 4 and Day 5 (2 hrs post ronacaleret dose), Day 6 (12 hrs and 14 and 16 hrs post plerixafor dose) and Day 14
Conditions Studied
Interventions
- DRUG Plerixafor
- DRUG Ronacaleret 100 mg
- DRUG Ronacaleret 400 mg
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-11-02 |
| Est. Completion | 2013-04-02 |
| Phase | Phase 1 |
What the finished NCT01802892 record still lists
NCT01802892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Transplantation, Stem Cell appearing as the primary indexed condition, and to 3 interventions - of which Plerixafor is the first listed.
NCT01802892 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01802892 about?
NCT01802892 is a clinical study titled "Study in Healthy Volunteers, to Evaluate the Safety, Efficacy and Dose Responses of SB-751689 (Ronacaleret)". 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 d...
What is the current status of trial NCT01802892?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-11-02. Estimated completion is 2013-04-02.
What conditions does trial NCT01802892 study?
This clinical trial studies the following conditions: Transplantation, Stem Cell.
What interventions are being tested in trial NCT01802892?
The interventions under investigation include: Plerixafor (DRUG), Ronacaleret 100 mg (DRUG), Ronacaleret 400 mg (DRUG).
Who is sponsoring clinical trial NCT01802892?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01802892 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01802892's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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