Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1006 · 2 trials · 2 indications
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
| Arm | Type | Description |
|---|---|---|
| Panel A: MK-1006 15/30/45 | EXPERIMENTAL | Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. |
| Panel B: MK-1006 60/80/60 fed | EXPERIMENTAL | Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. |
| Panel C: MK-1006 100/140/170 | EXPERIMENTAL | Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. |
| 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed) | EXPERIMENTAL | Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. |
| Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) | EXPERIMENTAL | Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed) | EXPERIMENTAL | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed) | EXPERIMENTAL | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo | EXPERIMENTAL | Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
| Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006 | EXPERIMENTAL | Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5 |
| 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006 | EXPERIMENTAL | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006 | EXPERIMENTAL | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo | EXPERIMENTAL | Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
| Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006 | EXPERIMENTAL | Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
| 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006 | EXPERIMENTAL | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5 |
| 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006 | EXPERIMENTAL | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
| Name | Type | Description |
|---|---|---|
| MK-1006 | DRUG | MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C. |
| Placebo | DRUG | Matching placebo to MK-1006 in a single oral dose |
| MK1006 | DRUG | MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose |
Inclusion Criteria: * Japanese male or female between 20 to 64 years of age * Diagnosis of type 2 diabetes * Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent Exclusion Criteria: * Subject has a history of type 1 diabetes mellitus * Subject has a clinic...
MK-1006 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for metabolic disease. It has been studied in Type 2 diabetes mellitus and non-insulin-dependent diabetes mellitus. It is a Phase 1 clinical candidate and is not described as approved; development has remained at the early clinical stage.
MK-1006 was studied as a treatment for Type 2 diabetes mellitus and non-insulin-dependent diabetes mellitus. Its clinical program focused on patients with these metabolic conditions rather than healthy volunteers. The studies evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in adults with Type 2 diabetes.
MK-1006 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 studies of the compound in patients with Type 2 diabetes mellitus. The drug remains an investigational asset in Merck's metabolic pipeline.
MK-1006 is in Phase 1 clinical development. Both recorded studies were Phase 1 trials, and both are now completed. There are no active trials listed for MK-1006, so the program's recorded clinical activity consists of completed early-stage studies in Type 2 diabetes.
Two completed Phase 1 trials are recorded for MK-1006: NCT00791661, a single dose study in Japanese Type 2 diabetes patients, and NCT00757601, which tested safety, tolerability, pharmacokinetics, and pharmacodynamics of MK1006. Both were randomized, double-blind, controlled studies in adults with Type 2 diabetes.
Yes, MK-1006 and MK1006 refer to the same investigational compound from Merck & Company, Inc. The hyphenated form MK-1006 and the unhyphenated form MK1006 appear in the trial records, including the Phase 1 study NCT00757601, which is titled using the MK1006 spelling.