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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: CTN XR (Clin); Drug: CTN XR (TBM); Drug: CTN SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT07253441

405-201-00157

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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174 participants in 14 patient groups

Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsules

Experimental group

Description:

Participants first receive a 1 × 328.8 mg CTN capsule, orally, on Day 1. Then, they receive 2 × 164.4 mg CTN capsules, orally, on Day 4.

Treatment:

Drug: CTN XR (TBM)

Cohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsules

Experimental group

Description:

Participants first receive 2 × 164.4 mg CTN capsules, orally, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, on Day 4.

Treatment:

Drug: CTN XR (TBM)

Cohort 2: CTN Fasted State, Then CTN Fed state

Experimental group

Description:

Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fasted state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fed state, on Day 4.

Treatment:

Drug: CTN XR (TBM)

Cohort 2: CTN Fed state, Then CTN Fasted state

Experimental group

Description:

Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fed state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fasted state, on Day 4.

Treatment:

Drug: CTN XR (TBM)

Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR

Experimental group

Description:

Participants first receive CTN 200 mg SR, tablets, orally on Day 1 followed by CTN 164.4 mg XR, capsules, orally on Day 4. Participants then receive CTN 400 mg SR, tablets, orally on Day 7, followed by CTN 328.8 mg XR, capsules, orally on Day 10.

Treatment:

Drug: CTN SR

Drug: CTN XR (TBM)

Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR

Experimental group

Description:

Participants first receive CTN 164.4 mg XR, capsules, orally on Day 1 followed by CTN 200 mg SR, tablets, orally on Day 4. Participants then receive CTN 328.8 mg XR, capsules, orally on Day 7, followed by CTN 400 mg SR, tablets, orally on Day 10.

Treatment:

Drug: CTN SR

Drug: CTN XR (TBM)

Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR

Experimental group

Description:

Participants first receive CTN 400 mg SR, tablets, orally on Day 1 followed by CTN 328.8 mg XR, capsules, orally on Day 4. Participants then receive CTN 200 mg SR, tablets, orally on Day 7, followed by CTN 164.4 mg XR, capsules, orally on Day 10.

Treatment:

Drug: CTN SR

Drug: CTN XR (TBM)

Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR

Experimental group

Description:

Participants first receive CTN 328.8 mg XR, capsules, orally on Day 1 followed by CTN 400 mg SR, tablets, orally on Day 4. Participants then receive CTN 164.4 mg XR, capsules, orally on Day 7, followed by CTN 200 mg SR, tablets, orally on Day 10.

Treatment:

Drug: CTN SR

Drug: CTN XR (TBM)

Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM)

Experimental group

Description:

Participants first receive CTN 164.4 mg XR (Clin), capsules, orally on Day 1 followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (Clin), capsules, orally on Day 7, followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 10.

Treatment:

Drug: CTN XR (Clin)

Drug: CTN XR (TBM)

Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin)

Experimental group

Description:

Participants first receive CTN 164.4 mg XR (TBM), capsules, orally on Day 1 followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (TBM), capsules, orally on Day 7, followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 10.

Treatment:

Drug: CTN XR (Clin)

Drug: CTN XR (TBM)

Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM)

Experimental group

Description:

Participants first receive CTN 328.8 mg XR (Clin), capsules, orally on Day 1 followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (Clin), capsules, orally on Day 7, followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 10.

Treatment:

Drug: CTN XR (Clin)

Drug: CTN XR (TBM)

Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin)

Experimental group

Description:

Participants first receive CTN 328.8 mg XR (TBM), capsules, orally on Day 1 followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (TBM), capsules, orally on Day 7, followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 10.

Treatment:

Drug: CTN XR (Clin)

Drug: CTN XR (TBM)

Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR

Experimental group

Description:

Participants first receive CTN 328.8 mg XR (TBM), capsules, orally, once a day (QD) from Day 1 to Day 5. Then, they receive CTN 400 mg SR, tablets, orally, from Day 6 to Day 10.

Treatment:

Drug: CTN SR

Drug: CTN XR (TBM)

Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM)

Experimental group

Description:

Participants first receive CTN 400 mg SR, tablets, orally from Day 1 to Day 5. Then, they will receive CTN 328.8 mg XR (TBM), capsules, orally, QD from Day 6 to Day 10.

Treatment:

Drug: CTN SR

Drug: CTN XR (TBM)