CTx-1301 Comparative Bioavailability Study

Inclusion Criteria

• Gender

a. Male or Female

• Age

a. Aged between 18 and 55 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.
• If sexually active, male subjects must use the double-barrier method (condom and spermicide) for birth control during the study and for 90 days following the last administration of study drug.
• If sexually active, female subjects of child-bearing potential must use an acceptable method of contraception, including abstinence from heterosexual intercourse, hormonal contraceptives, intrauterine device (IUD) with or without hormones, or double-barrier method (e.g. condom and spermicide), during the study and for 30 days following the last administration of study drug.
• Male subjects must agree not to donate sperm during the study and for 90 days following the last administration of study drug.
• Female subjects must agree not to donate eggs during the study and for 30 days following the last administration of study drug.
• Consent a. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any study-related activities are performed.
• Indication
• Subject must report history of diagnosis of ADHD.
• If subject is currently taking stimulant medication, they must be willing and able to safely abstain from any other ADHD treatment during 96 hrs. prior to check-in on Day -4 and through the complete duration of the study.
• General Health
• Good general health (in the opinion of an investigator) with no clinically significant or relevant abnormalities on medical history or physical examination which could affect the safety of the subject or study data.
• No vomiting or fever within 24-hours of check-in at Day -4
• Subject has sufficient venous access to allow cannulation and/or venipuncture to obtain the required volume of blood for this study.
• Subject must currently be taking or previously have taken a stimulant medication for ADHD.
• Smoking/Caffeine/Alcohol
• Subject must be able to refrain from smoking cigarettes 1 hour prior to dosing and 7 hours after dosing on dosing days. Subject must agree not to smoke more than one cigarette per hour, not to exceed 10 cigarettes per day.
• Subject must be able to refrain from caffeine for 10 hours prior to check-in at Day -4 and for the duration of the study.
• Subject must be able to refrain from using alcohol 48 hrs. prior to Day -4 and for the duration of the study.
• ADHD Medication History
• Subject's medication history suggests they will be able to tolerate a 40 mg dose of dexmethylphenidate.
• Subject must demonstrate tolerability of dexmethylphenidate assessed by tolerability day/test dose of 40 mg Focalin XR as evaluated by the investigator.

Exclusion Criteria

• 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. 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 cannot have 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).
• A family history of sudden cardiac or unex