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Not Applicable

CTx-1301 Fasted for Healthy Volunteers (Fed-Fast Trial)

Phase 1
Waitlist Available
Research Sponsored by Cingulate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gender a. Male or Female
Aged between 18 and 50 years inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-16 hrs
Awards & highlights

Fed-Fast Trial Summary

This trial will test how well a new 25 mg trimodal tablet of CTx-1301 is absorbed by the body compared to the current tablet.

Fed-Fast Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Fed-Fast Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-16 hrs
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-16 hrs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic parameter (AUC0-inf)
Pharmacokinetic parameter (AUC0-last)
Pharmacokinetic parameter (Cmax)
Secondary outcome measures
Partial AUC
Pharmacokinetic parameter Cl/F
Pharmacokinetic parameter K
+10 more

Fed-Fast Trial Design

2Treatment groups
Active Control
Group I: CTx-1301 FastedActive Control1 Intervention
Subjects will receive CTx-1301 in a fasted state.
Group II: CTx-1301 FedActive Control1 Intervention
Subjects will receive CTx-1301 in a fed state (high fat test meal).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cingulate TherapeuticsLead Sponsor
4 Previous Clinical Trials
247 Total Patients Enrolled
Matt Brams, MDStudy DirectorCingulate Therapeutics
3 Previous Clinical Trials
226 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Mar 2025