Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
Study NCT ID:
NCT04449250
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects
Sponsor:
Cingulate Therapeutics
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fed-Fast
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: