NCT04449250

Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects

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 Absorption and Bioavailability of CTx-1301 (Dexmethylphenidate)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (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 25 mg trimodal tablets in healthy adult volunteers.

Detailed description

An open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study with two treatments (fed vs fasted) in approximately 26 healthy adult subjects aged 18 to 50 years. Fed arm: Following an overnight fast of 10.5 hours, subjects should begin and finish consuming the test meal within 30 minutes, prior to administration of CTx-1301 (25 mg). CTx-1301 (25 mg) should be administered with approximately 240 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 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 fed treatment arm. Fasted arm: Following an overnight fast of 10.5 hours, subjects should be administered CTx-1301 (25 mg) with approximately 240 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 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. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal is used as the test meal for food-effect bioanalytical (BA) and fed bioequivalency (BE) studies. This test meal allows approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The test meal, eaten within 30 minutes prior to administration of CTx-1301, is 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 25 mg dose of CTx-1301 during each sequence. Subjects will serve as their own control.

Timeline

• Start date: 2022-09-14
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2020-06-26
• Last updated: 2022-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study