Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-2640 · 1 trial · 1 indication
| 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 ...
MK-2640 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. A completed trial evaluated its safety, pharmacokinetics, and pharmacodynamics in healthy participants and in participants with Type 1 Diabetes Mellitus.
MK-2640 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research to evaluate the drug's safety and effects in participants with Type 1 Diabetes Mellitus.
MK-2640 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for its safety, pharmacokinetics, and pharmacodynamics in a completed Phase 1 trial.
MK-2640 has one completed clinical trial, identified as NCT02269735. This three-part study evaluated the safety, pharmacokinetics, and pharmacodynamics of MK-2640 in healthy participants and in participants with Type 1 Diabetes Mellitus. The trial enrolled 74 participants and was controlled but not double-blind.
MK-2640 is the primary name for this investigational drug. No alternative names have been reported in the available clinical trial information. It is being studied under the trial identifier NCT02269735.