Trial Outcomes & Findings for Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED) (NCT NCT01059851)
NCT ID: NCT01059851
Last Updated: 2018-11-06
Results Overview
Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\[0-∞\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\[0-last\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).
COMPLETED
PHASE1
16 participants
Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
2018-11-06
Participant Flow
16 participants were enrolled in Part I of the study. Because the primary hypothesis was met in Part I, no participants were enrolled in Part II of the study.
Participant milestones
| Measure |
Participants With Severe Renal Impairment (Part I)
Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant.
|
Healthy Participants (Severe Impairment Controls) (Part I)
Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
|
Participants With Moderate Renal Impairment (Part II)
Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
Healthy Participants (Moderate Impairment Controls) (Part II)
Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
Participants With Mild Renal Impairment (Part II)
Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
Healthy Participants (Mild Impairment Controls) (Part II)
Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Participants With Severe Renal Impairment (Part I)
n=8 Participants
Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant.
|
Healthy Participants (Part I)
n=8 Participants
Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
48.1 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
49.4 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dosePopulation: All Treated Participants
Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\[0-∞\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\[0-last\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).
Outcome measures
| Measure |
Participants With Severe Renal Impairment (Part I)
n=8 Participants
Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant.
|
Healthy Participants (Part I)
n=8 Participants
Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
|
Participants With Mild Renal Impairment (Part II)
Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
Healthy Participants (Mild Impairment Controls) (Part II)
Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)
|
11.98 μM•hr
Interval 9.45 to 15.2
|
9.81 μM•hr
Interval 7.72 to 12.47
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dosePopulation: Per protocol, the decision to conduct Part II of study in moderate/mild renal impairment participants was conditional on results of AUC (0-∞) analysis in severe renal impairment participants (Part I). Based on results of Part I of study, Part II was not conducted and AUC(0-∞) analysis in moderate/mild renal impairment was not done.
Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\[0-∞\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\[0-last\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From administration of study drug through 14 days after administration of study drugPopulation: All Treated Participants
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
Outcome measures
| Measure |
Participants With Severe Renal Impairment (Part I)
n=8 Participants
Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant.
|
Healthy Participants (Part I)
n=8 Participants
Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
|
Participants With Mild Renal Impairment (Part II)
Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
Healthy Participants (Mild Impairment Controls) (Part II)
Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
2 participants
|
4 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From administration of study drug through 14 days after administration of study drugPopulation: All Treated Participants
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
Outcome measures
| Measure |
Participants With Severe Renal Impairment (Part I)
n=8 Participants
Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant.
|
Healthy Participants (Part I)
n=8 Participants
Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
|
Participants With Mild Renal Impairment (Part II)
Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
Healthy Participants (Mild Impairment Controls) (Part II)
Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Due to an AE
|
0 participants
|
0 participants
|
—
|
—
|
Adverse Events
Participants With Severe Renal Impairment (Part I)
Healthy Participants (Part I)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Severe Renal Impairment (Part I)
n=8 participants at risk
Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant.
|
Healthy Participants (Part I)
n=8 participants at risk
Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
|
|---|---|---|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/8 • From administration of study drug through 14 days after administration of study drug
|
25.0%
2/8 • From administration of study drug through 14 days after administration of study drug
|
|
Nervous system disorders
headache
|
0.00%
0/8 • From administration of study drug through 14 days after administration of study drug
|
37.5%
3/8 • From administration of study drug through 14 days after administration of study drug
|
|
Nervous system disorders
somnolence
|
12.5%
1/8 • From administration of study drug through 14 days after administration of study drug
|
0.00%
0/8 • From administration of study drug through 14 days after administration of study drug
|
|
Reproductive system and breast disorders
oligomenorrhoea
|
12.5%
1/8 • From administration of study drug through 14 days after administration of study drug
|
0.00%
0/8 • From administration of study drug through 14 days after administration of study drug
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER