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NCT01466335 · ClinicalTrials.gov registry record · Phase 1
An Adaptive Phase I Study to Evaluate the Safety, Efficacy and Dose Responses of Ronacaleret in Healthy Human Volunteers
A Phase 1 study of Bone Marrow Transplantation, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT01466335: Completed Phase 1 study of Bone Marrow Transplantation, sponsored by GlaxoSmithKline.
NCT01466335 is a Phase 1 study of Bone Marrow Transplantation that has completed, run by GlaxoSmithKline. The registered enrollment target is 39 participants, below the 345-participant average among 5 other Bone Marrow Transplantation trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01466335, a Phase 1 study of Bone Marrow Transplantation, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study 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. T
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ronacaleret (100mg tablet)
Study Locations (1)
New York
- GSK Investigational Site - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-10-27 |
| Est. Completion | 2012-03-05 |
| Phase | Phase 1 |
What the finished NCT01466335 record still lists
NCT01466335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 345-participant average among 5 other Bone Marrow Transplantation trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Bone Marrow Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01466335 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01466335 about?
NCT01466335 is a clinical study titled "An Adaptive Phase I Study to Evaluate the Safety, Efficacy and Dose Responses of Ronacaleret 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 bio...
What is the current status of trial NCT01466335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2011-10-27. Estimated completion is 2012-03-05.
What conditions does trial NCT01466335 study?
This clinical trial studies the following conditions: Bone Marrow Transplantation.
What interventions are being tested in trial NCT01466335?
The interventions under investigation include: Placebo (DRUG), Ronacaleret (100mg tablet) (DRUG).
Who is sponsoring clinical trial NCT01466335?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01466335 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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