NCT04138498

CTx-1301 Comparative Bioavailability Study

A Randomized, Single-dose, Four-sequence, Four-period, Crossover Study in Adult ADHD Subjects to Establish Safety, Tolerability, and Comparative Bioavailability of CTx-1301 (Dexmethylphenidate) to Focalin XR™ Under Fasted Conditions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cingulate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the bioavailability of CTx-1301 (dexmethylphenidate) to the registered listed drug, Focalin XR and to evaluate dose proportionality of CTx-1301. In addition, this study seeks to characterize the pharmacokinetics of dexmethylphenidate and evaluate the safety and tolerability of CTx-1301.

Detailed description

The study will comprise of a randomized, single-dose, four-sequence, four-period, in-clinic crossover study in approximately 36 adult ADHD subjects. All subjects considered eligible at Screening will proceed to tolerability test day, dosing 40 mg Focalin XR to evaluate safety and tolerability of the higher dose of d-MPH. If subject is able to safely tolerate the test dose, and meets all inclusion/exclusion criteria, they will be considered eligible for randomization into the study. All subjects will be randomized to receive four treatments throughout the course of the study; one CTx-1301 trimodal d-MPH tablet containing 6.25 mg d-MPH, one Focalin 5 mg XR capsule, one CTx-1301 50 mg tablet, and one 40 mg Focalin XR capsule. Administration of study drug will occur only on Assessment Days; no study drug will be administered during screening or unscheduled days (USVs). The lowest and highest doses of CTx-1301 (dexmethylphenidate, 6.25 and 50 mg) were selected to bridge to the lowest and highest doses of Focalin XR (dexmethylphenidate, 5 and 40 mg) in this comparative BA study.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Dexmethylphenidate 5 Mg Oral Capsule, Extended Release	Reference listed drug (RLD) for comparative BA evaluation
DRUG	Dexmethylphenidate 6.25 mg Tablet	Experimental drug for comparative BA evaluation
DRUG	Dexmethylphenidate 40 Mg Oral Capsule, Extended Release	Reference listed drug (RLD) for comparative BA evaluation
DRUG	Dexmethylphenidate 50 mg Tablet	Experimental drug for comparative BA evaluation

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2019-10-24
• Last updated: 2021-04-08
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study