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
NCT ID: NCT07253441
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
174 participants
INTERVENTIONAL
2024-08-29
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM)
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.
CTN XR (TBM)
Oral capsules
CTN XR (Clin)
Oral capsules
Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin)
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.
CTN XR (TBM)
Oral capsules
CTN XR (Clin)
Oral capsules
Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR
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.
CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM)
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.
CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR
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.
CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR
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.
CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin)
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.
CTN XR (TBM)
Oral capsules
CTN XR (Clin)
Oral capsules
Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM)
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.
CTN XR (TBM)
Oral capsules
CTN XR (Clin)
Oral capsules
Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsules
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.
CTN XR (TBM)
Oral capsules
Cohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsules
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.
CTN XR (TBM)
Oral capsules
Cohort 2: CTN Fasted State, Then CTN Fed state
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.
CTN XR (TBM)
Oral capsules
Cohort 2: CTN Fed state, Then CTN Fasted state
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.
CTN XR (TBM)
Oral capsules
Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR
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.
CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR
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.
CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
Interventions
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CTN XR (TBM)
Oral capsules
CTN SR
Oral tablets
CTN XR (Clin)
Oral capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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ICON Lenexa
Lenexa, Kansas, United States
ICON Salt Lake City
Millcreek, Utah, United States
Countries
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Other Identifiers
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405-201-00157
Identifier Type: -
Identifier Source: org_study_id
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