Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RDX5791 · 3 trials · 2 indications
Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams.
serum chemistry and hematology, ECGs, and clinical signs and symptoms
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Capsule that is identical in size and color to other treatments |
| Low Dose | EXPERIMENTAL | 10 mg capsule of tenapanor |
| Mid Dose | EXPERIMENTAL | 30 mg capsule of tenapanor |
| High Dose | EXPERIMENTAL | 100 mg capsule of tenapanor |
| 30 mg bid | EXPERIMENTAL | 30 mg of RDX5791 administered twice daily PO (60 mg total dose/day). |
| 30 mg tid | EXPERIMENTAL | 30 mg of RDX5791 administered three times daily PO (90 mg total dose/day). |
| 60 mg bid | EXPERIMENTAL | 60 mg of RDX5791 administered two times daily (120 mg total dose/day). |
| 15 mg bid | EXPERIMENTAL | 15 mg of RDX5791 administered two times daily (30 mg total dose/day). |
| 30 mg QD | EXPERIMENTAL | 30 mg of RDX5791 administered once daily (30 mg total dose/day). |
| Escalating dose bid | EXPERIMENTAL | 15 mg or 30 mg or 45 mg of RDX5791 administered two times daily (30, 60, or 90 mg total dose/day respectively). The stopping criteria for the dose escalation is based on Bristol Stool Score and AEs. |
| 30 mg bid with psyllium | EXPERIMENTAL | 30 mg of RDX5791 administered two times daily (60 mg total dose/day) with psyllium taken up to three times per day (maximum of 15 g psyllium/day). |
| RDX5791 10mg QD (SAD phase) | EXPERIMENTAL | 10mg of RDX5791 administered once daily PO fasting |
| RDX5791 50mg QD (SAD phase) | EXPERIMENTAL | 50mg of RDX5791 administered once daily PO fasting |
| RDX5791 150mg QD (SAD phase) | EXPERIMENTAL | 150mg of RDX5791 administered once daily PO fasting |
| RDX5791 450mg QD (SAD phase) | EXPERIMENTAL | 450mg of RDX5791 administered once daily PO fasting |
| RDX5791 900mg QD (SAD phase) | EXPERIMENTAL | 900mg of RDX5791 administered once daily PO fasting |
| RDX5791 3mg QD (MAD phase) | EXPERIMENTAL | 3mg of RDX5791 administered once daily PO fasting |
| RDX5791 10mg QD (MAD phase) | EXPERIMENTAL | 10mg of RDX5791 administered once daily PO fasting |
| RDX5791 30 mg QD (MAD phase) | EXPERIMENTAL | 30mg of RDX5791 administered once daily PO fasting |
| RDX5791 100 mg QD (MAD phase) | EXPERIMENTAL | 100mg of RDX5791 administered once daily PO fasting |
| Name | Type | Description |
|---|---|---|
| RDX5791 | DRUG | Capsule, QD |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subject meets Rome III criteria for IBS-C * If \> 50 years old, colonoscopy evaluation within 10 years * All ages, negative colonoscopy if any "warning symptoms" * Active disease during 2-week screening period * Compliant with IVRS Exclusion Criteria: * Subjects has IBS-D, I...
RDX5791 is an investigational small molecule being developed for constipation predominant irritable bowel syndrome (IBS-C). It has been studied in healthy volunteers as well. The drug is in clinical development and is not approved by the FDA.
RDX5791 is being developed by Ardelyx, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARDX. The company has conducted clinical trials of RDX5791 in the United States.
RDX5791 has completed Phase 2 clinical trials for constipation predominant irritable bowel syndrome (IBS-C). It has also completed Phase 1 trials in healthy volunteers. The drug is investigational and not yet approved.
RDX5791 has been studied in three completed trials: NCT01340053, a Phase 2 study in IBS-C with 186 participants; NCT02796131, a Phase 1 study in healthy volunteers with 105 participants; and NCT02819687, another Phase 1 study in healthy volunteers with 80 participants.
RDX5791 is the same as tenapanor, a small molecule being developed by Ardelyx for gastrointestinal conditions. The drug has been evaluated in clinical trials for constipation predominant irritable bowel syndrome and in healthy volunteer studies.