Adult Attention-deficit Hyperactivity Disorder (ADHD)Phase 1NCT02827513
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
A Phase 1 study testing CTN SR1, CTN XR1 and CTN XR2 in people with Adult Attention-deficit Hyperactivity Disorder (ADHD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Attention-deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- CTN SR1, CTN XR1 and CTN XR2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2015to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight within the normal range for height (body mass index [BMI] between 19-30 kg/m2 inclusive);
- Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential;
- 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;
- Be in general good health without clinically significant medical history;
- 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;
- Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test;
- Able and willing to give written informed consent.
Who cannot join
- 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;
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- 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;
- A history of, or current evidence for, suicidal ideation, based upon clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS);
- 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);
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
The study will be divided into three parts: A, B, C.
Part A: Single Dose, extended release (XR) Formulation Selection. This part of the study is a single dose, open label, four-period crossover design in a group of 16 healthy participants.
Part B: Multiple Ascending Dose. Part B has been designed to assess the effect of multiple doses of one formulation of XR CTN. This part of the study will be a double-blind, randomized, placebo-controlled design.
Part C: Food Effect. Part C has been designed to determine the effect food has on XR CTN. The XR formulation and dose administered will be selected after review of Part B data. This part will be an open-label, two-period crossover design in a group of 16 healthy participants.
- Being tested
- CTN SR1, CTN XR1, CTN XR2, CTN XR3
- Keywords
- Centanafadine, Adult attention-deficit hyperactivity disorder, Healthy participants
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTN SR1Drug
Also called Centanafadine
CTN XR1Drug
Also called Centanafadine
CTN XR2Drug
Also called Centanafadine
CTN XR3Drug
Also called Centanafadine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Drug: CTN SR1 |
| Arm 2 | Experimental | 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. Receives: Drug: CTN XR1 |
| Arm 3 | Experimental | 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. Receives: Drug: CTN XR2 |
| Arm 4 | Experimental | 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. Receives: Drug: CTN XR3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events and serious adverse events
Measured: Up to approximately 12 days
Secondary outcomes (9)
Maximum observed plasma concentration (Cmax) of Centanafadine (CTN) and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Time to maximum plasma concentration (Tmax) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Area under the plasma concentration-time curve from time zero until the last quantifiable time point (AUC0-last) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Apparent termination elimination rate constant (kel) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Apparent terminal elimination half-life (t1/2) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
last measurable plasma concentration (Clast) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) from AUC0-last +Clast/kel of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Dose normalized Cmax (Cmax/Dose) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Dose normalized AUC (AUC/Dose) of CTN and metabolite
Blood samples for the determination of plasma concentrations of CTN and metabolite will be collected following dosing as follows: For Part A- on Days 1, 4, 7, and 10 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 18; Days 2, 5, 8, and 11 at hour 24, 30, and 36; Days 3, 6, 9, and 12 at hour 48. For Part B- on Day 1 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 2 at Hour 24/Pre-dose; Day 4 at Pre-dose; Day 5 at Pre-dose, hour 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 18; Day 6 at hour 24 and 36; Day 7 at hour 48. For Part C- on Days 1 and 4 at Pre-dose, hour 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 18; Days 2 and 5 at hour 24, 30, and 36; Days 3 and 6 at hour 48
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Attention-deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827513
- Sponsor's protocol ID
- NVI-EB1020-105
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02827513
- Acronym / sponsor ID
- NVI-EB1020-105
- Keywords
- Centanafadine, Adult attention-deficit hyperactivity disorder, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be divided into three parts: A, B, C.
Part A: Single Dose, extended release (XR) Formulation Selection. This part of the study is a single dose, open label, four-period crossover design in a group of 16 healthy participants.
Part B: Multiple Ascending Dose. Part B has been designed to assess the effect of multiple doses of one formulation of XR CTN. This part of the study will be a double-blind, randomized, placebo-controlled design.
Part C: Food Effect. Part C has been designed to determine the effect food has on XR CTN. The XR formulation and dose administered will be selected after review of Part B data. This part will be an open-label, two-period crossover design in a group of 16 healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: CTN SR1Participants 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. |
| Arm 2 | Experimental | Drug: CTN XR1Participants 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. |
| Arm 3 | Experimental | Drug: CTN XR2Participants 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. |
| Arm 4 | Experimental | Drug: CTN XR3Participants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body weight within the normal range for height (body mass index [BMI] between 19-30 kg/m2 inclusive);
- Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential;
- 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;
- Be in general good health without clinically significant medical history;
- 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;
Key exclusion criteria (17 listed)
- Use of any of the following medications will exclude a participant:
- A history of, or current evidence for, suicidal ideation, based upon clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS);
- 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);
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTN SR1Also: Centanafadine | Drug | Arm 1 |
| CTN XR1Also: Centanafadine | Drug | Arm 2 |
| CTN XR2Also: Centanafadine | Drug | Arm 3 |
| CTN XR3Also: Centanafadine | Drug | Arm 4 |
Primary outcome
Number of participants with treatment emergent adverse events and serious adverse events
Time frame: Up to approximately 12 days
9 secondary outcomes
Maximum observed plasma concentration (Cmax) of Centanafadine (CTN) and metabolite
Time frame: 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
Time to maximum plasma concentration (Tmax) of CTN and metabolite
Time frame: 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
Area under the plasma concentration-time curve from time zero until the last quantifiable time point (AUC0-last) of CTN and metabolite
Time frame: 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
Apparent termination elimination rate constant (kel) of CTN and metabolite
Time frame: 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
Apparent terminal elimination half-life (t1/2) of CTN and metabolite
Time frame: 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
last measurable plasma concentration (Clast) of CTN and metabolite
Time frame: 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
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) from AUC0-last +Clast/kel of CTN and metabolite
Time frame: 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
Dose normalized Cmax (Cmax/Dose) of CTN and metabolite
Time frame: 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
Dose normalized AUC (AUC/Dose) of CTN and metabolite
Time frame: 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTN SR1, CTN XR1 and CTN XR2 in people with Adult Attention-deficit Hyperactivity Disorder (ADHD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events and serious adverse events (time frame: Up to approximately 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.