Trial Outcomes & Findings for A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014) (NCT NCT01628042)

Last Updated: 2018-12-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

Results posted on

2018-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Severe Renal Insufficiency Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Moderate Renal Insufficiency Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Mild Renal Insufficiency Participants received a single oral dose of vibegron 100 mg on Day 1.	Healthy Matched Control Participants Participants received a single oral dose of vibegron 100 mg on Day 1.
Overall Study STARTED	8	8	8	8
Overall Study COMPLETED	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Severe Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Moderate Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Mild Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Healthy Matched Control Participants n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Total n=32 Participants Total of all reporting groups
Age, Continuous	65 Years n=5 Participants	64 Years n=7 Participants	66 Years n=5 Participants	57 Years n=4 Participants	63 Years n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	24 Participants n=21 Participants

PRIMARY outcome

Timeframe: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With Severe Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Moderate Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Mild Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Healthy Matched Control Participants n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg	6337.17 nM•hr Interval 4940.96 to 8127.91	7137.53 nM•hr Interval 5615.7 to 9071.77	5156.07 nM•hr Interval 4045.44 to 6571.6	3466.04 nM•hr Interval 2663.08 to 4511.11

PRIMARY outcome

Timeframe: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With Severe Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Moderate Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Mild Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Healthy Matched Control Participants n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.
Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg	342.83 nM Interval 232.0 to 506.62	404.50 nM Interval 277.65 to 589.3	473.01 nM Interval 323.26 to 692.12	240.80 nM Interval 159.24 to 364.11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With Severe Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Moderate Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Mild Renal Insufficiency n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.	Healthy Matched Control Participants n=8 Participants Participants received a single oral dose of vibegron 100 mg on Day 1.
Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg	35.5 L/hr Interval 27.68 to 45.53	31.5 L/hr Interval 24.8 to 40.06	43.6 L/hr Interval 34.23 to 55.61	64.9 L/hr Interval 49.87 to 84.47

Adverse Events

Participants With Severe Renal Insufficiency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With Moderate Renal Insufficiency

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Participants With Mild Renal Insufficiency

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Healthy Matched Control Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Severe Renal Insufficiency n=8 participants at risk Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Moderate Renal Insufficiency n=8 participants at risk Participants received a single oral dose of vibegron 100 mg on Day 1.	Participants With Mild Renal Insufficiency n=8 participants at risk Participants received a single oral dose of vibegron 100 mg on Day 1.	Healthy Matched Control Participants n=8 participants at risk Participants received a single oral dose of vibegron 100 mg on Day 1.
Vascular disorders Hot flush	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Nervous system disorders Somnolence	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	25.0% 2/8 • Number of events 2 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Gastrointestinal disorders Nausea	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Infections and infestations Herpes zoster	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Nervous system disorders Dizziness	— 0/0 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	100.0% 1/1 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	25.0% 2/8 • Number of events 2 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Nervous system disorders Dizziness postural	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.
Nervous system disorders Headache	0.00% 0/8 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.	12.5% 1/8 • Number of events 1 • Up to 336 hours post-dose The All Subjects as Treated (AST) population, which consisted of all participants who received at least 1 dose of the investigational drug, was used for the safety analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER