In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted) (NCT07119073) | Clinical Trial Compass
CompletedPhase 1
In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)
United States25 participantsStarted 2024-10-31
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 50 mg trimodal tablets in healthy adult volunteers.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Gender
✓. Age
✓. Aged between 18 and 50 years inclusive. Weight and BMI
✓. Body weight ≥ 50 kg
✓. BMI ≥ 18 and ≤ 30
✓. Understands and is willing, able, and likely to comply with all study procedures and restrictions.
✓. Able to fully consume the required fed meal within 30 minutes without substitutions.
✓. If sexually active, male subjects must use an acceptable method of contraception, which includes the double-barrier method (condom and spermicide) or agree to remain abstinent from heterosexual intercourse from Qualification day, during the study, and for 90 days following the last administration of study drug.
Exclusion criteria
✕. Subject must be able to refrain from caffeine or xanthine-containing beverages or foods (e.g., tea, coffee, chocolate, cola) for 24 hours prior to admission on Qualification day, check-in at Day -1 and for the duration of the stay at the study center until EOS.
✕. Subject must be able to refrain from using alcohol 48 hrs. prior to admission on Qualification day, check-in at Day -1 and for the duration of the stay at the study center until EOS.
✕. 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, weight loss surgeries).
✕. Any clinically significant history including but not limited to arterial hypertension, pulmonary arterial hypertension, myocardial infarction, peripheral vascular disease, stroke, or evidence of other cardiovascular disease or disorder, including but not limited to ECG abnormalities such as:
✕. 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. 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.
✕. Subject has had suicidal thoughts within the last 6 months as supported by the Columbia Suicide Severity Rating Scale (C-SSRS).
✕. Positive test results for Human Immunodeficiency Virus (HIV)-1/HIV-2 antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb).