Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8777 · 2 trials · 2 indications
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.
An AE 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. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.
An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
An AE 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. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).
An AE 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 AE 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. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).
| Arm | Type | Description |
|---|---|---|
| MK-8777 FD→PBO | EXPERIMENTAL | Participants receive a fixed dose (FD) of MK-8777 100 mg twice each day (BID) for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo (PBO) BID for 3 weeks (Treatment Period 2). |
| PBO→MK-8777 FD | EXPERIMENTAL | Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2). |
| MK-8777 RD→PBO | EXPERIMENTAL | Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2). |
| PBO→MK-8777 RD | PLACEBO_COMPARATOR | Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2). |
| Part 1: Block A MK-8777 | EXPERIMENTAL | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. |
| Part 1: Block A Placebo | PLACEBO_COMPARATOR | Participants receive placebo BID for a total of 16 days. |
| Part 1: Block B MK-8777 | EXPERIMENTAL | Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. |
| Part 1: Block B Placebo | PLACEBO_COMPARATOR | Participants receive placebo BID for a total of 13 days. |
| Part 1: Block C MK-8777 | EXPERIMENTAL | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
| Part 1: Block C Placebo | PLACEBO_COMPARATOR | Participants receive placebo BID for a total of 10 days. |
| Part 1: Block D MK-8777 | EXPERIMENTAL | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
| Part 1: Block D Placebo | PLACEBO_COMPARATOR | Participants receive placebo BID for a total of 13 days. |
| Part 2: MK-8777 200 mg | EXPERIMENTAL | Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. |
| Part 2: MK-8777 800 mg | EXPERIMENTAL | Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days. |
| Name | Type | Description |
|---|---|---|
| MK-8777 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * are between 18-50 years, inclusive; * are male; or female who are non-pregnant, non-lactating and using an acceptable method of birth control (intrauterine device, double-barrier method, hormonal contraceptives); or female of non-childbearing potential if they are a) surgicall...
MK-8777 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for psychiatric conditions. It has been studied in Phase 2 clinical trials for major depressive disorder and attention deficit hyperactivity disorder (ADHD). It is a positive allosteric modulator and is not an approved medicine.
MK-8777 has been studied in clinical trials for two psychiatric indications: major depressive disorder and attention deficit hyperactivity disorder (ADHD) in adults. Both were Phase 2 studies. The drug is investigational and has not been approved for any use.
MK-8777 is a positive allosteric modulator of AMPA receptors, specifically the GRIA1, GRIA2, GRIA3, and GRIA4 subunits. Positive allosteric modulators enhance receptor activity rather than blocking it directly. This mechanism was the basis for studying the compound in depression and ADHD.
MK-8777 is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The compound was previously known as Org 26576 during earlier development before Merck's involvement.
MK-8777 is in Phase 2 development. Two Phase 2 trials have been completed, one in major depressive disorder and one in ADHD. No Phase 3 program has been reported, and the drug is not FDA approved.
Two completed Phase 2 trials studied MK-8777. NCT00610649 was a placebo-controlled, double-blind dose-finding study in major depressive disorder with 54 participants. NCT00610441 was a randomized, double-blind, placebo-controlled dose-finding study in adults with ADHD with 67 participants. Both trials are completed.
Yes, MK-8777 is also known as Org 26576. The earlier trial identifiers and titles use the Org 26576 name, while Merck's development code is MK-8777. Both names refer to the same investigational compound, a positive allosteric modulator of AMPA receptors.