A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)

A Phase 1 study testing Vibegron 100 mg in people with Overactive Bladder, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in participants with overactive bladder and to guide recommendations on potential dosing adjustments for individuals with varying degrees of renal… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Overactive Bladder
What is being tested?: Vibegron 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: 16 Jul 2012to 25 Jan 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index (BMI) ≤40 kg/m^2
Clinical diagnosis of renal insufficiency
Stable baseline health
Stable baseline health

Who cannot join

History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary disease
History of recent stroke, chronic seizures, or major neurological disorder
Demonstrated or suspected renal artery stenosis
Renal transplant or nephrectomy
History of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening
History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

Show all 29Show fewer

Unable to refrain from or anticipates the use of any medication including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of study drug, throughout the study, and until the post study visit
Unable to avoid taking diuretics within 4 hours prior to dosing and 4 hours post dosing; must be on a stable dose for at least approximately 2 weeks (or 5 half-lives of the compound, whichever is longer)
Unwilling to refrain from consuming any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats 2 weeks prior to dosing until the post-study visit
Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) within 4 weeks prior to administration of study drug
Plasma donation within 7 days prior to administration of study drug
Current regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
Nursing mother
Participation in another investigational study within 4 weeks of study enrollment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of stroke, chronic seizures, or major neurological disorder
History of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening
History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Unable to refrain from or anticipates the use of any medication including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the dose of study drug, throughout the study, until the post study visit
Unwilling to refrain from consuming any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats 2 weeks prior to dosing until the post study visit
Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) within 4 weeks prior to administration of study drug
Plasma donation within 7 days prior to administration of study drug
Current regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
Nursing mother
Participation in another investigational study within 4 weeks of study enrollment

About this study

Official title: An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency

Conditions: Overactive Bladder
Being tested: Vibegron 100 mg
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vibegron 100 mgDrug
Also called MK-4618
Vibegron tablets, orally, on Day 1

Study groups in NCT01628042
Study group	Role	What they receive
Participants With Severe Renal Insufficiency	Experimental	Participants will receive a single oral dose of vibegron 100 mg on Day 1. Receives: Drug: Vibegron 100 mg
Participants With Moderate Renal Insufficiency	Experimental	Participants will receive a single oral dose of vibegron 100 mg on Day 1. Receives: Drug: Vibegron 100 mg
Participants With Mild Renal Insufficiency	Experimental	Participants will receive a single oral dose of vibegron 100 mg on Day 1. Receives: Drug: Vibegron 100 mg
Healthy Matched Control Participants	Experimental	Participants receive a single oral dose of vibegron 100 mg on Day 1. Receives: Drug: Vibegron 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From 0 to Infinity (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 AUC0-∞ after a single oral dose of vibegron 100 mg.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
Maximum Plasma Concentration (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 Cmax after a single oral dose of vibegron 100 mg.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
Apparent Total Body Clearance (CL/F) 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.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201225 Jan 2013

First posted26 Jun 2012 (estimated)
Study start16 Jul 2012
Primary completion25 Jan 2013
Study completion25 Jan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01628042
Sponsor's protocol ID: 4618-014
Status last verified: Dec 2018
First submitted: 22 Jun 2012
Last updated: 24 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency
ClinicalTrials.gov ID: NCT01628042
Acronym / sponsor ID: 4618-014
Conditions: Overactive Bladder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Jul 2012 (actual)
Primary completion: 25 Jan 2013 (actual)
Study completion: 25 Jan 2013 (actual)
First posted: 26 Jun 2012 (estimated)
Results: Posted 9 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Participants With Severe Renal Insufficiency	Experimental	Drug: Vibegron 100 mgParticipants will receive a single oral dose of vibegron 100 mg on Day 1.
Participants With Moderate Renal Insufficiency	Experimental	Drug: Vibegron 100 mgParticipants will receive a single oral dose of vibegron 100 mg on Day 1.
Participants With Mild Renal Insufficiency	Experimental	Drug: Vibegron 100 mgParticipants will receive a single oral dose of vibegron 100 mg on Day 1.
Healthy Matched Control Participants	Experimental	Drug: Vibegron 100 mgParticipants receive a single oral dose of vibegron 100 mg on Day 1.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Body mass index (BMI) ≤40 kg/m^2
Clinical diagnosis of renal insufficiency
Stable baseline health
Stable baseline health

Key exclusion criteria (29 listed)

History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary disease
History of recent stroke, chronic seizures, or major neurological disorder
Demonstrated or suspected renal artery stenosis
Renal transplant or nephrectomy
History of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vibegron 100 mgAlso: MK-4618Vibegron tablets, orally, on Day 1	Drug	Healthy Matched Control Participants, Participants With Mild Renal Insufficiency, Participants With Moderate Renal Insufficiency, Participants With Severe Renal Insufficiency

Primary outcome

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
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.
Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
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.
Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
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.

Results and safety

Results posted to the registry on 9 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Severe Renal Insufficiency	8	8
Participants With Moderate Renal Insufficiency	8	8
Participants With Mild Renal Insufficiency	8	8
Healthy Matched Control Participants	8	8

Primary outcome: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose. Geometric mean (95% Confidence Interval). Unit: nM•hr

Measure	Participants With Severe Renal Insufficiency n = 8	Participants With Moderate Renal Insufficiency n = 8	Participants With Mild Renal Insufficiency n = 8	Healthy Matched Control Participants n = 8
Value	6337.17 (4940.96 to 8127.91)	7137.53 (5615.70 to 9071.77)	5156.07 (4045.44 to 6571.60)	3466.04 (2663.08 to 4511.11)

Participants With Severe Renal Insufficiency vs Healthy Matched Control Participants: Geometric least-squares mean ratio: 1.83 (90% CI 1.36 to 2.46), ANCOVA
Participants With Moderate Renal Insufficiency vs Healthy Matched Control Participants: Geometric least-squares mean ratio: 2.06 (90% CI 1.55 to 2.74), ANCOVA
Participants With Mild Renal Insufficiency vs Healthy Matched Control Participants: Geometric least-squares mean ratio: 1.49 (90% CI 1.11 to 2.00), ANCOVA

Population analysed: Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.

Primary outcome: Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Participants With Severe Renal Insufficiency n = 8	Participants With Moderate Renal Insufficiency n = 8	Participants With Mild Renal Insufficiency n = 8	Healthy Matched Control Participants n = 8
Value	342.83 (232.00 to 506.62)	404.50 (277.65 to 589.30)	473.01 (323.26 to 692.12)	240.80 (159.24 to 364.11)

Participants With Severe Renal Insufficiency vs Healthy Matched Control Participants: Geometric least-squares mean ratio: 1.42 (90% CI 0.89 to 2.27), ANCOVA
Participants With Moderate Renal Insufficiency vs Healthy Matched Control Participants: Geometric least-squares mean ration: 1.68 (90% CI 1.07 to 2.63), ANCOVA
Participants With Mild Renal Insufficiency vs Healthy Matched Control Participants: Geometric least-squares mean ratio: 1.96 (90% CI 1.23 to 3.13), ANCOVA

Population analysed: PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.

Primary outcome: Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose. Geometric mean (95% Confidence Interval). Unit: L/hr

Measure	Participants With Severe Renal Insufficiency n = 8	Participants With Moderate Renal Insufficiency n = 8	Participants With Mild Renal Insufficiency n = 8	Healthy Matched Control Participants n = 8
Value	35.5 (27.68 to 45.53)	31.5 (24.80 to 40.06)	43.6 (34.23 to 55.61)	64.9 (49.87 to 84.47)

Participants With Severe Renal Insufficiency vs Healthy Matched Control Participants: Geometric least squares mean ratio: 0.55 (90% CI 0.41 to 0.74), ANCOVA
Participants With Moderate Renal Insufficiency vs Healthy Matched Control Participants: Geometric least squares mean ratio: 0.49 (90% CI 0.36 to 0.65), ANCOVA
Participants With Mild Renal Insufficiency vs Healthy Matched Control Participants: Geometric least squares mean ratio: 0.67 (90% CI 0.50 to 0.90), ANCOVA

Adverse events

Time frame: Up to 336 hours post-dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Severe Renal Insufficiency	0 of 8 (0%)	0 of 8 (0%)	Not reported
Participants With Moderate Renal Insufficiency	0 of 8 (0%)	4 of 8 (50%)	Not reported
Participants With Mild Renal Insufficiency	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Healthy Matched Control Participants	0 of 8 (0%)	2 of 8 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Overactive Bladder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vibegron 100 mg in people with Overactive Bladder, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg (time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01628042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.