Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-4618
Vibegron · 4 trials · 3 indications
Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.
Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.
Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.
| Arm | Type | Description |
|---|---|---|
| Part 1: placebo | PLACEBO_COMPARATOR | Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 3 mg | EXPERIMENTAL | Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 15 mg | EXPERIMENTAL | Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 50 mg | EXPERIMENTAL | Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 100 mg | EXPERIMENTAL | Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: tolterodine ER 4 mg | ACTIVE_COMPARATOR | Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg | EXPERIMENTAL | Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning. |
| Part 2: placebo | PLACEBO_COMPARATOR | Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks. |
| Part 2: vibegron 100 mg | EXPERIMENTAL | Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks. |
| Part 2: tolterodine ER 4 mg | ACTIVE_COMPARATOR | Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks. |
| Part 2: vibegron 100 mg + tolterodine ER 4 mg | EXPERIMENTAL | Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks. |
| Extension Study: vibegron 50 mg | EXPERIMENTAL | Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks. |
| Extension Study: vibegron 100 mg | EXPERIMENTAL | Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks. |
| Extension Study: tolterodine ER 4 mg | EXPERIMENTAL | Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks. |
| Extension Study: vibegron 100 mg + tolterodine ER 4 mg | EXPERIMENTAL | Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks. |
| Participants With Moderate Hepatic Insufficiency | EXPERIMENTAL | Participants with moderate hepatic insufficiency will receive a single oral dose of vibegron 100 mg. |
| Healthy Matched Control Participants | EXPERIMENTAL | Participants who are healthy will receive a single oral dose of vibegron 100 mg. |
| Participants With Mild Hepatic Insufficiency | EXPERIMENTAL | Participants with mild hepatic insufficiency will receive a single oral dose of vibegron 100 mg. |
| Participants With Severe Renal Insufficiency | EXPERIMENTAL | Participants will receive a single oral dose of vibegron 100 mg on Day 1. |
| Participants With Moderate Renal Insufficiency | EXPERIMENTAL | Participants will receive a single oral dose of vibegron 100 mg on Day 1. |
| Participants With Mild Renal Insufficiency | EXPERIMENTAL | Participants will receive a single oral dose of vibegron 100 mg on Day 1. |
| Panel A: MK-4618 + Met → PBO + Met | EXPERIMENTAL | Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1. |
| Panel A: PBO + Met → MK-4618 + Met | EXPERIMENTAL | Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1. |
| Panel B: MK-4618 + Amlo → PBO + Amlo | EXPERIMENTAL | Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1. |
| Panel B: PBO + Amlo → MK-4618 + Amlo | EXPERIMENTAL | Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1. |
| Name | Type | Description |
|---|---|---|
| Vibegron | DRUG | Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning. |
| Tolterodine ER | DRUG | Participants received one tolterodine ER 4 mg capsule, taken orally once a day. |
| Placebo matching vibegron | DRUG | Participants received placebo matching vibegron tablets, taken orally each morning. |
| Placebo matching tolterodine ER | DRUG | Participants received placebo matching tolterodine ER capsule, taken orally each morning. |
| Vibegron 100 mg | DRUG | Vibegron tablets, orally, on Day 1 |
| MK-4618 | DRUG | Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 |
| Placebo for MK-4618 | DRUG | Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 |
| Metoprolol | DRUG | Previously prescribed daily dose of open-label metoprolol for the duration of the study |
| Amlodipine | DRUG | Previously prescribed daily dose of open-label amlodipine for the duration of the study |
Inclusion Criteria: * If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study * Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB...
Vibegron is being studied for the treatment of overactive bladder, a condition marked by urgency and frequency of urination. It is an investigational small molecule developed by Merck & Company, Inc. under the ticker MRK. Clinical work to date has focused on patients with overactive bladder and on how the drug behaves in people with hepatic or renal impairment.
Vibegron targets ADRB3, the beta-3 adrenergic receptor, and acts as an agonist at that receptor. Agonist activity at ADRB3 is the mechanism under study for overactive bladder. The drug is a small molecule, and its target class is described as an agonist.
Vibegron is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor behind the clinical program for the drug in overactive bladder, including the pharmacokinetic studies in hepatic and renal insufficiency and the Phase 2 efficacy and safety study.
Vibegron is in Phase 1 development based on its current stage, and it is investigational rather than approved. The program includes completed Phase 1 pharmacokinetic studies and a completed Phase 2 study in overactive bladder. No active trials are currently listed for the drug.
Vibegron has been studied in completed trials including NCT01737684, a Phase 1 single-dose pharmacokinetic study in adults with hepatic insufficiency, NCT01628042, a Phase 1 single-dose pharmacokinetic study in participants with renal insufficiency, and NCT01314872, a Phase 2 efficacy and safety study in participants with overactive bladder.