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

NCT07119073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers in Fed and Fasted State

Interventions

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.

Sponsors & Collaborators

  • Cingulate Therapeutics

    lead INDUSTRY

Principal Investigators

  • Matt Brams, MD · Cingulate Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2024-12-21
Completion
2024-12-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119073 on ClinicalTrials.gov