A Single and Multiple-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8521 in Subjects

Registration

Registration

NCT02055547

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

61

Start

2013-05-10

Primary completion

2013-09-17

Lead sponsor

Merck Sharp & Dohme LLC

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:MK-8521 35μg; DRUG:MK-8521 100μg; DRUG:MK-8521 125μg; DRUG:MK-8521 150μg; DRUG:MK-8521 175μg; DRUG:MK-8521 200μg; DRUG:MK-8521 300μg; DRUG:MK-8521 50/72μg; DRUG:MK-8521 72/125μg; DRUG:MK-8521 100/150μg; DRUG:MK-8521 125/150μg; DRUG:Placebo

Results posted

TRUE

Individual participant data sharing

YES

Secondary identifiers

EUDRACT_NUMBER:2013-000083-28; OTHER:MK-8521-002

Registered primary outcomes

• Number of Participants Who Experienced at Least One Adverse Event (AE) (Part 1) [From Day 1 through post-trial visit (Up to 8 weeks)]
• Number of Participants Who Discontinued Treatment Due to an AE (Part 1) [Up to 8 weeks (Part 1)]
• Area Under the Concentration Time Curve of MK-8521 From 0 to Infinity (AUC0-∞) After a Single Dose (Part 1) [Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)]
• Peak Plasma Concentration (Cmax) of Participants Treated With a Single Dose of MK-8521 (Part 1) [Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)]
• Time Taken to Reach Cmax (Tmax) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 1) [Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)]
• Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 1) [Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)]
• Number of Participants With an Adverse Event (AE) (Part 2) [From Day 1 through post-trial visit (Up to 7 weeks)]
• Number of Participants Who Discontinued Treatment Due to an AE (Part 2) [Up to 7 weeks (Part 2)]
• AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panels C, D, and E) [Days 1, 5 and 10 (Part 2) (Panels C, D, E)]
• AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panel F) [Days 1, 7 and 14 (Part 2) (Panel F)]
• Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E) [Days 1, 5 and 10 (Part 2) (Panels C, D, E)]
• Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F) [Days 1, 7 and 14 (Part 2) (Panel F)]
• Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E) [Days 1, 5 and 10 (Part 2) (Panels C, D, E)]
• Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F) [Days 1, 7 and 14 (Part 2) (Panel F)]
• Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E) [Days 1, 5 and 10 (Part 2) (Panels C, D, E)]
• Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F) [Days 1, 7 and 14 (Part 2) (Panel F)]
• Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part C, D, and E) [Days 1, 5 and 10 (Part 2) (Panels C, D, E)]
• Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part F) [Days 1, 7 and 14 (Part 2) (Panel F)]
• Number of Participants With an Adverse Event (AE) (Part 3) [Up to 6 weeks (Part 3)]
• Number of Participants Who Discontinued Treatment Due to an AE (Part 3) [Up to 6 weeks (Part 3)]
• Average Concentration (Cave) of MK-8521 Corresponding to Slope of Insulin Secretion Rate/Glucose (ISR/G) During Graded Glucose Infusion (GGI) at Tmax After a Single Dose of MK-8521 (Part 3) [From -10 to 160 minutes after GGI on Day 1 (Part 3)]