Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in… (NCT07486895) | Clinical Trial Compass
CompletedPhase 1
Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects
United States44 participantsStarted 2023-03-08
Plain-language summary
The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
✓. In good health as determined by:
✓. Medical history
✓. Physical examination
✓. Electrocardiogram (ECG)
✓. Serum/urine chemistry, hematology, and serology tests.
✓. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion criteria
✕. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
✕. History of drug and/or alcohol abuse within 2 years prior to screening.
✕. History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
✕. History of any significant drug allergy or known or suspected hypersensitivity.
✕
What they're measuring
1
Maximum Plasma Concentration (Cmax) of Centanafadine
Timeframe: Up to Day 5
2
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
Timeframe: Up to Day 5
3
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
Timeframe: Up to Day 5
Trial details
NCT IDNCT07486895
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.