Approval Probability
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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 developed by GSK plc (ticker GSK). It has been studied in Phase 1 clinical trials in healthy volunteers for bone marrow transplantation, stem cell transplantation, and osteoporosis. It is a calcium-sensing receptor antagonist and has also been referred to as Ronacaleret 100 mg or the Ronacaleret 100mg tablet.
Ronacaleret targets the calcium-sensing receptor, also known as CASR. It acts as an antagonist at this receptor, meaning it blocks receptor signaling. This target class and mechanism distinguish it as a small molecule therapeutic candidate studied in early clinical development.
Ronacaleret is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 clinical trials of the drug, including studies conducted in the United States in healthy volunteers and healthy postmenopausal females.
Ronacaleret is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. All three recorded trials are Phase 1 studies, and all are completed, with no active trials currently listed.
Ronacaleret has been evaluated in three completed Phase 1 trials: NCT01802892 in stem cell transplantation, NCT01466335 in bone marrow transplantation, and NCT00651534 in osteoporosis. These studies enrolled healthy volunteers in the United States and included randomized, double-blind, placebo-controlled designs.
Yes, SB-751689 is another name for Ronacaleret. The Phase 1 study NCT01802892 was titled to evaluate the safety, efficacy, and dose responses of SB-751689 (Ronacaleret). Searches for Ronacaleret 100 mg or the Ronacaleret 100mg tablet refer to the same compound.