CompletedPhase 1

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

United States27 participantsStarted 2022-09-14

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Gender a. Male or Female
✓. Age
✓. Aged between 18 and 50 years inclusive.
✓. Weight and BMI
✓. Body weight ≥ 50 kg
✓. BMI ≥ 18 and ≤ 35
✓. Compliance
✓. Understands and is willing, able, and likely to comply with all study procedures and restrictions.

Exclusion criteria

✕. Subject must be able to refrain from caffeine or xanthine-containing beverages or foods (e.g., tea, coffee, chocolate, cola) for 10 hours prior to check-in at Day -1 and for the duration of the study.
✕. Subject must be able to refrain from using alcohol 48 hrs. prior to Day -1 and for the duration of the study.
✕. Medical History
✕. Current and/or recurrent disease or illness that, in the opinion of an investigator, could affect the study conduct, study outcome, subject safety, or pharmacokinetic (PK) assessments (e.g., hepatic disorders, renal insufficiency, non-self-limiting gastrointestinal disorders, congestive heart failure).
✕. Current and/or previous history of any other serious, severe or unstable psychiatric illness which in the opinion of the investigator, may require treatment (e.g. ADD/ADHD, anxiety, psychosis, mood disorder, motor tics or suicidality) or make the subject unlikely to fully complete the study, and/or any condition that presents undue risk from the study medication or procedures.

What they're measuring

Pharmacokinetic parameter (Cmax)

Timeframe: Hour 0 to hour 28

Pharmacokinetic parameter (AUC0-inf)

Timeframe: Hour 0 to hour 28

Pharmacokinetic parameter (AUC0-last)

Timeframe: Hour 0 to hour 28

Trial details

NCT IDNCT04449250

SponsorCingulate Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-14

View on ClinicalTrials.gov More Healthy Volunteers in Fed and Fasted State trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Gender a. Male or Female
✓. Age
✓. Aged between 18 and 50 years inclusive.
✓. Weight and BMI
✓. Body weight ≥ 50 kg
✓. BMI ≥ 18 and ≤ 35
✓. Compliance
✓. Understands and is willing, able, and likely to comply with all study procedures and restrictions.

Exclusion criteria

✕. Subject must be able to refrain from caffeine or xanthine-containing beverages or foods (e.g., tea, coffee, chocolate, cola) for 10 hours prior to check-in at Day -1 and for the duration of the study.
✕. Subject must be able to refrain from using alcohol 48 hrs. prior to Day -1 and for the duration of the study.
✕. Medical History
✕. Current and/or recurrent disease or illness that, in the opinion of an investigator, could affect the study conduct, study outcome, subject safety, or pharmacokinetic (PK) assessments (e.g., hepatic disorders, renal insufficiency, non-self-limiting gastrointestinal disorders, congestive heart failure).
✕. Current and/or previous history of any other serious, severe or unstable psychiatric illness which in the opinion of the investigator, may require treatment (e.g. ADD/ADHD, anxiety, psychosis, mood disorder, motor tics or suicidality) or make the subject unlikely to fully complete the study, and/or any condition that presents undue risk from the study medication or procedures.