Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexmethylphenidate · 2 trials · 1 indication
Maximum Concentration
Area Under the Curve from time 0 to infinity
Area Under the Curve from time 0 to 28 hrs
| Arm | Type | Description |
|---|---|---|
| CTx-1301 Fasted | ACTIVE_COMPARATOR | Subjects will receive CTx-1301 in a fasted state |
| CTx-1301 Fed | ACTIVE_COMPARATOR | Subjects will receive CTx-1301 in a fed state (high fat test meal) |
| Name | Type | Description |
|---|---|---|
| Dexmethylphenidate | DRUG | Subjects will be randomized to one of two sequences. Subjects will be dosed with 50 mg dose of Cox-1301 during each sequence. Subjects will serve as their own control. |
Inclusion Criteria: 1. Gender a. Male or Female 2. Age 1. Aged between 18 and 50 years inclusive. Weight and BMI <!-- --> 1. Body weight ≥ 50 kg 2. BMI ≥ 18 and ≤ 30 4\. Compliance 1. Understands and is willing, able, and likely to comply with all study procedures and restricti...
Dexmethylphenidate is being studied in healthy volunteers in fed and fasted states. It is an investigational small molecule being developed by Cingulate Inc. for use in these clinical studies, which assess the effect of food on the drug. It is not approved and remains in clinical development.
Cingulate Inc. (NASDAQ: CING) is developing Dexmethylphenidate. The company is conducting clinical trials to evaluate the drug in healthy volunteers, with studies completed in the United States. Cingulate Inc. is the developer behind this investigational small molecule.
Dexmethylphenidate is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers in fed and fasted states. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical testing.
Dexmethylphenidate has two completed Phase 1 trials: NCT04449250, a fed-fast crossover study assessing the effect of food with CTx-1301 in 27 healthy subjects, and NCT07119073, an in-clinic crossover study with two treatments (fed vs fasted) in 25 subjects. Both were conducted in the United States.
Yes, Dexmethylphenidate is also known as CTx-1301. The clinical trial NCT04449250 references CTx-1301 in its title, indicating that this is the same drug. Both names refer to the investigational small molecule being developed by Cingulate Inc. for studies in healthy volunteers.