Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
2. In good health as determined by:
* Medical history
* Physical examination
* Electrocardiogram (ECG)
* Serum/urine chemistry, hematology, and serology tests.
3. 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.
You may not be if
1. 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.
2. History of drug and/or alcohol abuse within 2 years prior to screening.
3. 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.
4. History of any significant drug allergy or known or suspected hypersensitivity.
5. 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.
6. Any participant who, in the opinion of the investigator, should not participate in the trial.
