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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02827513




Registration number
NCT02827513
Ethics application status
Date submitted
6/07/2016
Date registered
11/07/2016
Date last updated
18/02/2022

Titles & IDs
Public title
A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) in Young Healthy Subjects
Scientific title
A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) (Formerly Called EB-1020) in Young Healthy Subjects
Secondary ID [1] 0 0
NVI-EB1020-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Attention-deficit Hyperactivity Disorder (ADHD) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Arm 1 - Participants will receive sustained release (SR) Tablet Formulation 1 (SR1) containing 100 mg of Centanafadine (CTN) (2 x 100 mg tablets taken orally by mouth \[PO\] in the morning at starting at approximately 7 am and 2 x 100 mg tablets PO 5 hours later) for a total daily dose (TTD) of 400 mg on Days 1, 4, 7, and 10.

Experimental: Arm 2 - Participants will receive extended release (XR) Tablet Formulation 1 (XR1) containing 400 mg of CTN (1 x 400 mg tablet PO in the morning) on Days 1, 4, 7, and 10.

Experimental: Arm 3 - Participants will receive XR Tablet Formulation 2 (XR2) containing 400 mg of CTN (1 x 400 mg tablet PO in the morning) on Days 1, 4, 7, and 10.

Experimental: Arm 4 - Participants will receive XR Tablet Formulation 3 (XR3) containing 400 mg of CTN (1 x 400 mg tablet PO in the morning) on Days 1, 4, 7, and 10.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment emergent adverse events and serious adverse events
Timepoint [1] 0 0
Up to approximately 12 days
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of Centanafadine (CTN) and metabolite
Timepoint [1] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [2] 0 0
Time to maximum plasma concentration (Tmax) of CTN and metabolite
Timepoint [2] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve from time zero until the last quantifiable time point (AUC0-last) of CTN and metabolite
Timepoint [3] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [4] 0 0
Apparent termination elimination rate constant (kel) of CTN and metabolite
Timepoint [4] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [5] 0 0
Apparent terminal elimination half-life (t1/2) of CTN and metabolite
Timepoint [5] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [6] 0 0
last measurable plasma concentration (Clast) of CTN and metabolite
Timepoint [6] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [7] 0 0
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) from AUC0-last +Clast/kel of CTN and metabolite
Timepoint [7] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [8] 0 0
Dose normalized Cmax (Cmax/Dose) of CTN and metabolite
Timepoint [8] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6
Secondary outcome [9] 0 0
Dose normalized AUC (AUC/Dose) of CTN and metabolite
Timepoint [9] 0 0
For Part A: From Day 1 to 12; For Part B: Day 1, Day 2, Day 4, Day 5, Day 6, and Day 7; For Part C: Day 1 to 6

Eligibility
Key inclusion criteria
1. Body weight within the normal range for height (body mass index [BMI] between 19-30 kg/m2 inclusive);
2. Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential;
3. Women of child-bearing potential must agree to use adequate; contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy;
4. Be in general good health without clinically significant medical history;
5. Have clinical laboratory test results that are within the laboratory reference range; or if out of range are not clinically relevant and are acceptable to the Investigator and Sponsor medical representative;
6. Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test;
7. Able and willing to give written informed consent.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Use of any of the following medications will exclude a participant:

* investigational compound within 30 days prior to Screening;
* antipsychotic, anxiolytic, or sedative-hypnotic medication within 30 days prior to Screening;
* any antidepressant medication within 30 days prior to Screening;
* clonidine within 30 days prior to Screening;
* cough/cold preparations containing stimulants/sympathomimetic agent within 7 days prior to Day -1;
* norepinephrine reuptake inhibitors, such as tomoxetine (STRATTERA®) within 30 days prior to Day -1;
* antihypertensive agents, including diuretics, are not permitted at any time prior to or during the study;
* sedating antihistamines (as a single preparation or in combination) within 7 days prior to Day -1;
* sympathomimetics, appetite suppressants, modafinil, methylphenidate, amphetamine and pemoline within 7 days prior to Day -1;
* Use over the counter medications within 7 days of Investigational Product administration, with the exception of simple analgesics such as paracetamol, oral non-steroidal anti-inflammatory agents and the oral contraceptive pill (if applicable);
* Use of any herbal preparations and melatonin is prohibited and should be discontinued prior to Day -1. The process for discontinuing use of herbal preparations and melatonin prior to Day -1 is at the discretion of the Investigator;
2. A history of, or current evidence for, suicidal ideation, based upon clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS);
3. A history of known or suspected seizures, spasms, infantile spasms, febrile convulsions, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits);
4. Subject has a known history of hypertension or Subject has a supine systolic blood pressure (SBP) =140 mm Hg or diastolic blood pressure (DBP) =90 mm Hg. No more than one repeat measurement will be permitted;
5. Subject has a known history of orthostatic hypotension or has an orthostatic blood pressure (BP) drop of =20 mm Hg (based on the drop between supine and standing [3 minutes] SBP) at Screening or Day -1;

Note: The eligibility criteria list is not exhaustive.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the safety, tolerance, food effect, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended release (XR) formulations of Centanafadine (CTN) in Young Healthy participants.
Trial website
https://clinicaltrials.gov/study/NCT02827513
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02827513