NCT07119073

In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)

An Open-label, Randomized, Single-dose, Two-period, Two Treatment (Fed vs Fasted), Two Sequence, Crossover Study in Healthy Adult Subjects to Assess the Effect of Food on the Bioavailability of CTx-1301 (Dexmethylphenidate)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Cingulate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 50 mg trimodal tablets in healthy adult volunteers.

Detailed description

Fasted Arm: Following an overnight fast of at least 10.5 hours prior to dosing, subjectsshould be administered CTx-1301 (50 mg) with approximately240 mL (8 fluidounces) of water. No food should be allowed for at least 4 hours post-dose.Water can be allowed as desired except for at least one hour before and at least one hour after drug administration. Subjects should receive standardized meals as defined in the study schedule for the fasted treatment arm. Fed Arm: Following an overnight fast of at least 10.5 hours prior to dosing, subjects should begin consuming the test meal 30 minutes prior to administration ofCTx-1301. CTx-1301 (50 mg) should be administered 30 minutes after thestart of the meal. CTx-1301 (50 mg) should be administered with approximately240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for at leastone hour before and at least one hour after drug administration. Subjects will receive the high-fat meal as described below for the fed treatment arm and standardized meals for all other meals. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (800 to 1000 calories) meal is used as the test meal for food-effect bioavailability (BA) and fed bioequivalence (BE) studies. This test meal allows 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The test meal must be entirely consumed within 30 minutes prior to administration of CTx-1301; the test meal consists of two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk.

Conditions

• Healthy Volunteers in Fed and Fasted State

Interventions

Type	Name	Description
DRUG	Dexmethylphenidate	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.

Timeline

• Start date: 2024-10-31
• Primary completion: 2024-12-21
• Completion: 2024-12-27
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study