Trial Outcomes & Findings for A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031) (NCT NCT01767688)

NCT ID: NCT01767688

Last Updated: 2018-09-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
• Results posted on: 2018-09-10

Participant Flow

Adult (18 to 80 years of age) males and females participated in the study. Eight participants with moderate hepatic impairment, and eight healthy control participants (matched according to age, weight, gender, and creatinine clearance [CLCr] or estimated glomerular filtration rate [eGFR]), were enrolled.

Participant milestones

Measure	Moderate Hepatic Impairment Group Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)

Baseline characteristics by cohort

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.	Total n=16 Participants Total of all reporting groups
Age, Continuous	57 Years FULL_RANGE 6.45 • n=5 Participants	53 Years FULL_RANGE 8.45 • n=7 Participants	55 Years FULL_RANGE 7.55 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose

Population: All participants that received omarigliptin 25 mg.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)	23.3 µM*hr Interval 20.2 to 26.9	24.9 µM*hr Interval 21.8 to 28.3

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose

Population: All participants that received omarigliptin 25 mg.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)	22.4 µM*hr Interval 19.8 to 25.4	23.8 µM*hr Interval 21.2 to 26.7

SECONDARY outcome

Timeframe: 168 hours post-dose

Population: All participants that received omarigliptin 25 mg.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Plasma Concentration at 168 Hours After Dosing (C168h)	15.7 nM Interval 10.7 to 23.0	19.4 nM Interval 13.7 to 27.4

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose

Population: All participants that received omarigliptin 25 mg.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Maximum Observed Plasma Concentration (Cmax)	572 nM Interval 523.0 to 626.0	554 nM Interval 511.0 to 600.0

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose

Population: All participants that received omarigliptin 25 mg.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Time to Maximum Observed Plasma Drug Concentration (Tmax)	2 hr Interval 1.0 to 4.0	2 hr Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose

Population: All participants that received omarigliptin 25 mg.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Apparent Terminal Phase Half-life (t½)	34.6 hr Geometric Coefficient of Variation 17.4	34.5 hr Geometric Coefficient of Variation 13.4

SECONDARY outcome

Timeframe: Up to 14 days post-dose

Population: All participants that received omarigliptin 25 mg.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Number of Participants Experiencing Adverse Events (AEs)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 14 days post-dose

Population: All participants that received omarigliptin 25 mg.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Measure	Moderate Hepatic Impairment Group n=8 Participants Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 Participants Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Number of Participants Discontinued From Study Due to AEs	0 Participants	0 Participants

Adverse Events

Moderate Hepatic Impairment Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Matched Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Moderate Hepatic Impairment Group n=8 participants at risk Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.	Healthy Matched Control Group n=8 participants at risk Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 • AEs were monitored for 14 days after receiving omarigliptin 25 mg.	12.5% 1/8 • Number of events 1 • AEs were monitored for 14 days after receiving omarigliptin 25 mg.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor will provide separate guidance on the criteria for publication of clinical trial data when contacted for permission to publish.
• Publication restrictions are in place

Restriction type: OTHER