CompletedPhase 1

A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels

United States174 participantsStarted 2024-08-29

Plain-language summary

The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.

Who can participate

Age range18 Years – 55 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

✓. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
✓. In good health as determined by:
✓. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the 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 investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
✕. History of drug and/or alcohol abuse within 2 years prior to screening.
✕. History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies.
✕. History of any significant drug allergy or known or suspected hypersensitivity.
✕. A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site.
✕. Any participant who, in the opinion of the investigator, should not participate in the trial.

What they're measuring

Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN

Timeframe: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve Calculated From Time 0 to Time t (AUCt) of CTN

Timeframe: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of CTN

Timeframe: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohort 5: Cmax of CTN

Timeframe: Up to Day 11

Cohort 5: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady-state of CTN XR

Timeframe: Up to Day 11

Cohort 5: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of CTN SR

Timeframe: 24 Hours postdose up to Day 10

Cohort 5: Minimum Plasma Concentration During a Dosing Interval (Cmin) of CTN

Timeframe: Up to Day 11

Trial details

NCT IDNCT07253441

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Attention Deficit Disorder With Hyperactivity trials

Plain-language summary

Who can participate

Age range18 Years – 55 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

✓. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
✓. In good health as determined by:
✓. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the 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 investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
✕. History of drug and/or alcohol abuse within 2 years prior to screening.
✕. History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies.
✕. History of any significant drug allergy or known or suspected hypersensitivity.
✕. A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site.
✕. Any participant who, in the opinion of the investigator, should not participate in the trial.

What they're measuring

Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN

Timeframe: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve Calculated From Time 0 to Time t (AUCt) of CTN

Timeframe: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of CTN

Timeframe: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12

Cohort 5: Cmax of CTN

Timeframe: Up to Day 11

Cohort 5: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady-state of CTN XR

Timeframe: Up to Day 11

Cohort 5: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of CTN SR

Timeframe: 24 Hours postdose up to Day 10

Cohort 5: Minimum Plasma Concentration During a Dosing Interval (Cmin) of CTN

Timeframe: Up to Day 11