Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02269735 | A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) | PHASE1 | COMPLETED | 74 | — | — | Nov 26, 2014 | Jul 29, 2016 | Jan 15, 2019 | - | — |
| Arm | Type | Description |
|---|---|---|
| Part I: MK-2640 (Panel A) | EXPERIMENTAL | Part I: Lowest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel B) | EXPERIMENTAL | Part I: Low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel C) | EXPERIMENTAL | Part I: Medium-low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel D) | EXPERIMENTAL | Part I: Medium dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel E) | EXPERIMENTAL | Part I: Medium-high dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel F) | EXPERIMENTAL | Part I: High dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel G) | EXPERIMENTAL | Part 1: Highest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part II: MK-2640 followed by RHI | EXPERIMENTAL | Part II: MK-2640 infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II. |
| Part II: RHI followed by MK-2640 | EXPERIMENTAL | Part II: RHI infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II. |
| Part III: MK-2640 followed by RHI | EXPERIMENTAL | Part III: MK-2640 infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III. |
| Part III: RHI followed by MK-2640 | EXPERIMENTAL | Part III: RHI infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III. |
| Name | Type | Description |
|---|---|---|
| MK-2640 | DRUG | MK-2640 intravenous infusion administered to participant in a fasted state |
| Regular Human Insulin (RHI) | BIOLOGICAL | RHI 100 units/mL intravenous infusion to maintain target glycemic level |
| Dextrose | DRUG | Dextrose 20% or 50% intravenous infusion for approximately 9 or 7 hours, as appropriate to attain a target glycemic level |
| Insulin aspart | BIOLOGICAL | Insulin aspart subcutaneous injection or intravenous infusion the evening before each period in Parts II and III to achieve/maintain glycemic target. |
| Rescue medication | DRUG | Rescue medication may be administered for hypotension or mild to moderate infusion reaction. Rescue medication may include epinephrine, antihistamines, steroids, or acetaminophen/paracetamol. |
Inclusion Criteria (Part I): * healthy male or healthy female of non-child bearing potential * in good health * is a non-smoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months Inclusion Criteria (Parts II and III): * male or ...