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

NCT04449250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-10-20

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 25 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 25 mg dose of CTx-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
2022-09-14
Primary Completion
2022-10-14
Completion
2022-10-14
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 NCT04449250 on ClinicalTrials.gov