Attention-Deficit/Hyperactivity DisorderPhase 1NCT02163915
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
A Phase 1 study testing TAK-137 in people with Attention-Deficit/Hyperactivity Disorder, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- TAK-137
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is a male or female adult who is 18 to 55 years of age, inclusive.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
- Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
- Is willing to discontinue all medications to treat adult ADHD (eg, stimulants, antidepressants) and all other medications and dietary products as specified in the protocol, from Day -7 until Follow-up phone call (Day 14).
Who cannot join
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has uncontrolled, clinically significant neurologic (including mildly abnormal or significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder (other than ADHD), or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
- Has a positive urine drug result for drugs of abuse other than amphetamines or other medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day -1).
- Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
- Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Multiple Rising Doses of TAK-137 in Adult Subjects With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).
Read the detailed description
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose and to assess how TAK-137 is metabolized in people with attention-deficit/ hyperactivity disorder (ADHD). This study will look at side effects and lab results in people who take TAK-137. This study is designed as a randomized, sequential-cohort, multiple rising dose study.
Therefore, the TAK-137 2 mg Cohort will not start until the TAK-137 0.5 mg Cohort has completed, etc.
This trial will be conducted in the United States. The overall time to participate in this study is up to 42 days. Participants will make at least 2 visits to the clinic, including one 9-day period of confinement to the clinic. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.
A decision was made to terminate this study so that emerging data from preclinical studies could be further assessed.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- TAK-137, TAK-137 Placebo
- Keywords
- Drug therapy
- 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.
TAK-137Drug
TAK-137 tablets
TAK-137 PlaceboDrug
TAK-137 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TAK-137 0.5 mg | Experimental | TAK-137 0.5 mg, tablets, orally once on Days 1-7. Receives: Drug: TAK-137 |
| Cohort 2: TAK-137 2 mg | Experimental | TAK-137 2 mg, tablets, orally once on Days 1-7. Receives: Drug: TAK-137 |
| Cohort 3: TAK-137 5 mg | Experimental | TAK-137 5 mg, tablets, orally once on Days 1-7. Receives: Drug: TAK-137 |
| Cohort 4: TAK-137 10 mg | Experimental | TAK-137 10 mg, tablets, orally once on Days 1-7. Receives: Drug: TAK-137 |
| Cohort 5: TAK-137 TBD | Experimental | TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3. Receives: Drug: TAK-137 |
| Cohorts 1-5: Placebo | Experimental | TAK-137 placebo-matching tablets, orally, once on Days 1-7. Receives: Drug: TAK-137 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Day 1 up to Day 14
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Measured: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Measured: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
Measured: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose
Measured: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Measured: Day 1 up to Day 8
Secondary outcomes (4)
Cmax: Maximum Observed Plasma Concentration for TAK-137
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
Maximum observed steady-state plasma concentration during a dosing interval.
Measured: Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Measured: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: To allow evaluation of emerging non-clinical data (see detailed description below)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163915
- Sponsor's protocol ID
- TAK-137_102
- Other IDs
- U1111-1152-6846
- Status last verified
- Jun 2016
- First submitted
- 12 Jun 2014
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Multiple Rising Doses of TAK-137 in Adult Subjects With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02163915
- Acronym / sponsor ID
- TAK-137_102
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To allow evaluation of emerging non-clinical data (see detailed description below)
- Enrolment
- 47 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Posted 11 Jul 2016
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 characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).
Detailed description
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose and to assess how TAK-137 is metabolized in people with attention-deficit/ hyperactivity disorder (ADHD). This study will look at side effects and lab results in people who take TAK-137. This study is designed as a randomized, sequential-cohort, multiple rising dose study.
Therefore, the TAK-137 2 mg Cohort will not start until the TAK-137 0.5 mg Cohort has completed, etc.
This trial will be conducted in the United States. The overall time to participate in this study is up to 42 days. Participants will make at least 2 visits to the clinic, including one 9-day period of confinement to the clinic. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.
A decision was made to terminate this study so that emerging data from preclinical studies could be further assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TAK-137 0.5 mg | Experimental | Drug: TAK-137TAK-137 0.5 mg, tablets, orally once on Days 1-7. |
| Cohort 2: TAK-137 2 mg | Experimental | Drug: TAK-137TAK-137 2 mg, tablets, orally once on Days 1-7. |
| Cohort 3: TAK-137 5 mg | Experimental | Drug: TAK-137TAK-137 5 mg, tablets, orally once on Days 1-7. |
| Cohort 4: TAK-137 10 mg | Experimental | Drug: TAK-137TAK-137 10 mg, tablets, orally once on Days 1-7. |
| Cohort 5: TAK-137 TBD | Experimental | Drug: TAK-137TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3. |
| Cohorts 1-5: Placebo | Experimental | Drug: TAK-137 PlaceboTAK-137 placebo-matching tablets, orally, once on Days 1-7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is a male or female adult who is 18 to 55 years of age, inclusive.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
- Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
- Is willing to discontinue all medications to treat adult ADHD (eg, stimulants, antidepressants) and all other medications and dietary products as specified in the protocol, from Day -7 until Follow-up phone call (Day 14).
Key exclusion criteria (7 listed)
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has uncontrolled, clinically significant neurologic (including mildly abnormal or significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder (other than ADHD), or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
- Has a positive urine drug result for drugs of abuse other than amphetamines or other medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day -1).
- Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
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 |
|---|---|---|
| TAK-137TAK-137 tablets | Drug | Cohort 1: TAK-137 0.5 mg, Cohort 2: TAK-137 2 mg, Cohort 3: TAK-137 5 mg, Cohort 4: TAK-137 10 mg, Cohort 5: TAK-137 TBD |
| TAK-137 PlaceboTAK-137 placebo-matching tablets | Drug | Cohorts 1-5: Placebo |
Primary outcome
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Day 1 up to Day 14
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Day 1 up to Day 8
4 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for TAK-137
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
Time frame: Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Time frame: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
Time frame: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director Clinical Science study director
Takeda
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 TAK-137 in people with Attention-Deficit/Hyperactivity Disorder, run by Takeda at 1 site in United States.
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 4 inclusion and 7 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 11 Jul 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Day 1 up to Day 14). The study lists 6 primary outcomes in all. 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 11 Jul 2016.