Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SR verapamil
verapamil · 1 trial · 1 indication
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
The specified pharmacokinetic parameter will be summarised using descriptive statistics
| Arm | Type | Description |
|---|---|---|
| RV521 plus Itraconazole | EXPERIMENTAL | RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D7 plus Itraconazole 100 mg capsules for oral administration, a 200 mg dose administered once daily on D4 - D10, inclusive |
| RV521 plus Verapamil | EXPERIMENTAL | RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D11 plus Verapamil, 80 mg tablets for oral administration, an 80 mg dose administered TDS daily on D4 - D14, inclusive |
| RV521 plus Rifampicin | EXPERIMENTAL | RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D10 plus Rifadin, Rifampicin, 300 mg capsules for oral administration, a 600 mg dose administered once daily on D4 - D10, inclusive |
| RV521 plus Midazolam | EXPERIMENTAL | RV521 drug substance in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15 |
| Placebo plus Midazolam | PLACEBO_COMPARATOR | Placebo for RV521 in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15 |
| Name | Type | Description |
|---|---|---|
| Itraconazole | DRUG | Itraconazole capsules |
| Verapamil | DRUG | Verapamil tablets |
| Rifampicin | DRUG | Rifampicin capsules |
| Midazolam | DRUG | Midazolam oromucosal solution |
| Placebo for RV521 | DRUG | Placebo for RV521 capsules |
| RV521 | DRUG | RV521 capsules |
Inclusion Criteria: * Age 18 to 45 years, inclusive * Willing to comply with protocol defined contraception requirements * In good health with no history of major medical conditions * A body mass index (BMI) of 18 - 25 kg/m2 Exclusion Criteria: * Evidence of any clinically significant or currentl...
Verapamil is being studied as a small molecule treatment for Respiratory Syncytial Virus Infections. It is in Phase 1 clinical development, and the completed trial enrolled healthy adult volunteers rather than patients with active RSV infection. It is investigational and has not been approved for RSV.
Verapamil targets calcium channels, specifically CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It acts as a blocker of these channels. This calcium channel blocking activity is the basis for its investigation in Respiratory Syncytial Virus Infections.
Pfizer, Inc. (ticker PFE) is the developer of verapamil for Respiratory Syncytial Virus Infections. The company is responsible for the clinical program evaluating the drug in this infectious disease indication.
Verapamil is in Phase 1 clinical development for Respiratory Syncytial Virus Infections. It is investigational and has not been approved for this indication. The Phase 1 program includes one completed trial.
Verapamil has been studied in one Phase 1 trial for Respiratory Syncytial Virus Infections: NCT03782662, titled A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants. The trial was completed, enrolled 82 healthy adult participants in the United Kingdom, and was randomized, double-blind, and placebo-controlled.
Yes, verapamil is also known as SR verapamil. Both names refer to the same small molecule drug being developed by Pfizer for Respiratory Syncytial Virus Infections.