Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK1006 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
| Placebo | DRUG | Placebo capsule to match MK1006 1, 10, and 20 mg. Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose |
Inclusion Criteria: * Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C * Female participants must be postmenopausal or otherwise unable to have children * Participant has a body mass index (BMI) less than or equal to 42 kg/m\^2 at t...
MK-1006 is an investigational small molecule being developed for Type 2 Diabetes Mellitus and non-insulin-dependent diabetes mellitus. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with these conditions.
MK-1006 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus and non-insulin-dependent diabetes mellitus.
MK-1006 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one involving 25 patients with Type 2 Diabetes Mellitus and another involving 24 Japanese patients with non-insulin-dependent diabetes mellitus.
MK-1006 has completed two Phase 1 clinical trials. The first, NCT00757601, studied the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1006 in 25 patients with Type 2 Diabetes Mellitus. The second, NCT00791661, was a single-dose study in 24 Japanese patients with non-insulin-dependent diabetes mellitus.
Yes, MK-1006 and MK1006 refer to the same investigational drug. Clinical trial NCT00757601 is titled 'A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)', confirming that both names are used interchangeably for this compound.