Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ronacaleret · 3 trials · 3 indications
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
| Arm | Type | Description |
|---|---|---|
| Ronacaleret 100 mg | EXPERIMENTAL | Subjects will receive ronacaleret (100 mg once daily) for 5 consecutive days, given in conjunction with a single dose of plerixafor (0.24 mg/kg) SC on the evening of Day 5. |
| Ronacaleret 400 mg | EXPERIMENTAL | Subjects will receive ronacaleret (400 mg once daily) for 5 consecutive days, given in conjunction with a single dose of plerixafor (0.24 mg/kg) SC on the evening of Day 5. |
| Ronacaleret 100mg once daily | EXPERIMENTAL | 1 x 100mg oral tablet |
| Ronacaleret 100mg twice daily | EXPERIMENTAL | 1 x 100mg oral tablet twice daily |
| Ronacaleret 200mg once daily | EXPERIMENTAL | 2 x 100mg oral tablet |
| Ronacaleret 200mg twice daily | EXPERIMENTAL | 2 x 100mg tablets twice daily |
| Ronacaleret 400mg once daily | EXPERIMENTAL | 4 x 100mg tablets |
| Placebo | PLACEBO_COMPARATOR | Matching number of identical placebo tablets |
| Name | Type | Description |
|---|---|---|
| Ronacaleret 100 mg | DRUG | Subjects in the Ronacaleret 100 mg group received one tablet orally of ronacaleret 100 mg for 5 consecutive days. |
| Ronacaleret 400 mg | DRUG | Subjects in the Ronacaleret 400 mg group received four tablets orally of ronacaleret 100 mg daily for 5 consecutive days. |
| Plerixafor | DRUG | Subjects in each group received a single dose of plerixafor (0.24mg/kg) SC on the evening of the Day 5 dosing approximately 12 hours before collection of CD34+ cells on day 6. |
| Ronacaleret (100mg tablet) | DRUG | 100mg tablet |
| Placebo | DRUG | matching placebo tablet |
| Ronacaleret | DRUG | - |
Inclusion Criteria: * A male or female between 18 and 65 years of age (inclusive). * Healthy as determined by a physician, based on a medical evaluation and with an estimated Glomerular Filtration Rate (GFR) of \>=60 mL/min /1.73 m\^2 using the four variable Modification of Diet in Renal Disease (M...
Ronacaleret is an investigational small molecule being studied for osteoporosis, transplantation, stem cell, and bone marrow transplantation. It is being developed by GSK plc (GSK) and is currently in Phase 1 clinical development. Ronacaleret is not approved by the FDA and remains under investigation.
Ronacaleret is a small molecule developed by GSK plc (GSK). Its specific molecular target has not been disclosed in available information. The drug is being investigated for potential use in osteoporosis and transplantation-related conditions, but its mechanism of action is not publicly detailed.
Ronacaleret is being developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials and is not yet approved for any indication.
Ronacaleret is in Phase 1 clinical development. It has completed three Phase 1 trials, all of which are finished. The drug remains investigational and has not received FDA approval. GSK plc (GSK) is the developer of Ronacaleret.
Ronacaleret has completed three Phase 1 clinical trials: NCT00651534, NCT01466335, and NCT01802892. These trials evaluated the drug in healthy volunteers for conditions including osteoporosis, bone marrow transplantation, and stem cell transplantation. All trials are completed, with no active trials currently ongoing.
Yes, Ronacaleret is also known as SB-751689. The clinical trial NCT01802892, titled 'Study in Healthy Volunteers, to Evaluate the Safety, Efficacy and Dose Responses of SB-751689 (Ronacaleret)', confirms that SB-751689 is an alternative name for Ronacaleret.