Attention Deficit Hyperactivity Disorder (ADHD)Phase 1NCT02578030
Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD
A Phase 1 study testing SHP465 12.5mg and SHP465 25mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 3 sites in United States.
Trial summary
To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- SHP465 12.5mg and SHP465 25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Oct 2015to 10 Nov 2015
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 17 years inclusive at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for a primary diagnosis of ADHD based on an accepted ADHD diagnostic instrument and documented in the subject's medical record. Subject's ADHD is currently adequately controlled with an amphetamine-based product.
- Subject is functioning at an age appropriate level intellectually, as determined by the investigator.
- Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- Ability to swallow a capsule of investigational product whole.
Who cannot join
- Current use of any ADHD medication other than an amphetamine-based product.
- History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD
- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment
- Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms
- Subject meets DSM-V diagnosis of conduct disorder.
- Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
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- Subject is underweight based on Centers for Disease Control and Prevention (CDC) body mass index (BMI)- for-age sex-specific values
- Subject is significantly overweight based on CDC BMI-for-age sex specific values
- Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
- Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study
- Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's Disorder. Subject has a history of tics that are judged to be exclusionary.
- Subject's blood pressure measurements exceed the 90th percentile for age, sex, and height
- Subject has a known history of hypertension.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject has any clinically significant ECG or clinically significant laboratory abnormality
- Subject has abnormal thyroid function
- Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any ingredients.
- History of alcohol or other substance abuse within the last year. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
- Use Within 30 days prior to the first dose of investigational product:
- have used an investigational product
- have been enrolled in a clinical study (including vaccine)
- have had any substantial changes in eating habits
- A positive screen for alcohol or drugs of abuse. A positive hepatitis B surface antigen (HBsAg); hepatitis C virus (HCV); or HIV antibody screen.
- Use of tobacco in any form in the last 30 days
- Prior screen failure, enrollment, or participation in this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Houston Clinical Research
Houston, Texas, 77098
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
QPS MRA
Miami, Florida, 33143
About this study
Official title: A Phase 1, Open-label Study of the Pharmacokinetics of d- and L-amphetamine After a Single Dose of SHP465 12.5 mg or 25 mg Administered to Children and Adolescents Aged 6 to17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).
- Being tested
- SHP465 12.5mg, SHP465 25mg
- 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.
SHP465 12.5mgDrug
SHP465 25mgDrug
| Study group | Role | What they receive |
|---|---|---|
| SHP465 12.5 mg | Experimental | A single dose of SHP465 12.5 mg for Subjects aged 6-12 years Receives: Drug: SHP465 12.5mg |
| SHP465 25 mg | Experimental | A single dose of SHP465 25 mg for Subjects aged 13-17 years Receives: Drug: SHP465 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Drug Concentration (Cmax) of Dextroamphetamine (d-amphetamine) in Plasma
Maximum concentration occurring at time of maximum observed concentration of d-amphetamine during a dosing interval.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Maximum Observed Drug Concentration (Cmax) for Levoamphetamine (l-amphetamine) in Plasma
Maximum observed concentration of l-amphetamine during a dosing interval.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Time to Reach Maximum Observed Drug Concentration (Tmax) of Dextroamphetamine (d-amphetamine) in Plasma
Time to reach maximum observed drug concentration of d-amphetamine during a dosing interval.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Time to Reach Maximum Observed Drug Concentration (Tmax) of Levoamphetamine (l-amphetamine) in Plasma
Time to reach maximum observed drug concentration of l-amphetamine during a dosing interval.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Area Under the Curve From Zero to Infinity (AUC0-infinity) of Dextroamphetamine (d-amphetamine) in Plasma
AUC0-infinity was calculated using the observed value of the last non-zero concentration of d-amphetamine in plasma.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Area Under the Curve From Zero to Infinity (AUC0-infinity) of Levoamphetamine (l-amphetamine) in Plasma
AUC0-infinity was calculated using the observed value of the last non-zero concentration of l-amphetamine in plasma.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Dextroamphetamine (d-amphetamine) in Plasma
Area under the curve from the time of dosing to the last measurable concentration of d-amphetamine in plasma.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Levoamphetamine (l-amphetamine) in Plasma
Area under the curve from the time of dosing to the last measurable concentration of l-amphetamine in plasma.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Terminal Half-life (t½) of Dextramphetamine (d-amphetamine) in Plasma
Terminal half-life is the time measured for the plasma concentration of d-amphetamine to decrease by one half.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Terminal Half-life (t½) of Levoamphetamine (l-amphetamine) in Plasma
Terminal half-life is the time measured for the plasma concentration of l-amphetamine to decrease by one half.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Total Body Clearance for Extravascular Administration (CL/F) of Dextroamphetamine (d-amphetamine)
Total body clearance for extravascular administration of d-amphetamine divided by the fraction of dose absorbed.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Total Body Clearance for Extravascular Administration (CL/F) of Levoamphetamine (l-amphetamine)
Total body clearance for extravascular administration of l-amphetamine divided by the fraction of dose absorbed.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Volume of Distribution After Extravascular Administration (Vz/F) of Dextroamphetamine (d-amphetamine)
Volume of distribution for d-amphetamine based on the terminal phase following extravascular administration divided by the fraction of dose absorbed.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Volume of Distribution After Extravascular Administration (Vz/F) of Levoamphetamine (l-amphetamine)
Volume of distribution for l-amphetamine based on the terminal phase following extravascular administration divided by the fraction of dose absorbed.
Measured: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Secondary outcomes (3)
Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered as treatment-emergent (TEAE) if it had a start date and time on or after the dose of investigational product and no later than 72 hours after dosing, or if it had a start date and time before the date and time of the dose of investigational product, but increased in severity on or after the date and time of the dose of investigational product and no later than 72 hours after dosing.
Measured: From start of study drug administration up to follow-up (up to 9 days)
Number of Participants With TEAE Related to Vital signs, Electrocardiogram (ECG), and Clinical Laboratory Tests
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Vital signs included blood pressure, pulse rate, respiratory rate, and body temperature. ECG was analysed as 12-lead ECG. Clinical laboratory test is considered for biochemistry, Hematology and Urinalysis.
Measured: From start of study drug administration up to follow-up (up to 9 days)
Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Measured: Baseline up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start24 Oct 2015
- Primary completion10 Nov 2015
- Study completion10 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578030
- Sponsor's protocol ID
- SHP465-111
- Status last verified
- May 2021
- First submitted
- 5 Oct 2015
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Pharmacokinetics of d- and L-amphetamine After a Single Dose of SHP465 12.5 mg or 25 mg Administered to Children and Adolescents Aged 6 to17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02578030
- Acronym / sponsor ID
- SHP465-111
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2015 (actual)
- Primary completion
- 10 Nov 2015 (actual)
- Study completion
- 10 Nov 2015 (actual)
- First posted
- 16 Oct 2015 (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.
To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHP465 12.5 mg | Experimental | Drug: SHP465 12.5mgA single dose of SHP465 12.5 mg for Subjects aged 6-12 years |
| SHP465 25 mg | Experimental | Drug: SHP465 25mgA single dose of SHP465 25 mg for Subjects aged 13-17 years |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6 to 17 years inclusive at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for a primary diagnosis of ADHD based on an accepted ADHD diagnostic instrument and documented in the subject's medical record. Subject's ADHD is currently adequately controlled with an amphetamine-based product.
- Subject is functioning at an age appropriate level intellectually, as determined by the investigator.
- Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
Key exclusion criteria (25 listed)
- Current use of any ADHD medication other than an amphetamine-based product.
- History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD
- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment
- Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms
- Subject meets DSM-V diagnosis of conduct disorder.
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 |
|---|---|---|
| SHP465 12.5mg | Drug | SHP465 12.5 mg |
| SHP465 25mg | Drug | SHP465 25 mg |
Primary outcome
Maximum Observed Drug Concentration (Cmax) of Dextroamphetamine (d-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Maximum concentration occurring at time of maximum observed concentration of d-amphetamine during a dosing interval.
Maximum Observed Drug Concentration (Cmax) for Levoamphetamine (l-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Maximum observed concentration of l-amphetamine during a dosing interval.
Time to Reach Maximum Observed Drug Concentration (Tmax) of Dextroamphetamine (d-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Time to reach maximum observed drug concentration of d-amphetamine during a dosing interval.
Time to Reach Maximum Observed Drug Concentration (Tmax) of Levoamphetamine (l-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Time to reach maximum observed drug concentration of l-amphetamine during a dosing interval.
Area Under the Curve From Zero to Infinity (AUC0-infinity) of Dextroamphetamine (d-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
AUC0-infinity was calculated using the observed value of the last non-zero concentration of d-amphetamine in plasma.
Area Under the Curve From Zero to Infinity (AUC0-infinity) of Levoamphetamine (l-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
AUC0-infinity was calculated using the observed value of the last non-zero concentration of l-amphetamine in plasma.
Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Dextroamphetamine (d-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Area under the curve from the time of dosing to the last measurable concentration of d-amphetamine in plasma.
Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Levoamphetamine (l-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Area under the curve from the time of dosing to the last measurable concentration of l-amphetamine in plasma.
Terminal Half-life (t½) of Dextramphetamine (d-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Terminal half-life is the time measured for the plasma concentration of d-amphetamine to decrease by one half.
Terminal Half-life (t½) of Levoamphetamine (l-amphetamine) in Plasma
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Terminal half-life is the time measured for the plasma concentration of l-amphetamine to decrease by one half.
Total Body Clearance for Extravascular Administration (CL/F) of Dextroamphetamine (d-amphetamine)
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Total body clearance for extravascular administration of d-amphetamine divided by the fraction of dose absorbed.
Total Body Clearance for Extravascular Administration (CL/F) of Levoamphetamine (l-amphetamine)
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Total body clearance for extravascular administration of l-amphetamine divided by the fraction of dose absorbed.
Volume of Distribution After Extravascular Administration (Vz/F) of Dextroamphetamine (d-amphetamine)
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Volume of distribution for d-amphetamine based on the terminal phase following extravascular administration divided by the fraction of dose absorbed.
Volume of Distribution After Extravascular Administration (Vz/F) of Levoamphetamine (l-amphetamine)
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Volume of distribution for l-amphetamine based on the terminal phase following extravascular administration divided by the fraction of dose absorbed.
3 secondary outcomes
Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to follow-up (up to 9 days)
Number of Participants With TEAE Related to Vital signs, Electrocardiogram (ECG), and Clinical Laboratory Tests
Time frame: From start of study drug administration up to follow-up (up to 9 days)
Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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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.
Study Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHP465 12.5mg and SHP465 25mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 3 sites 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 6 inclusion and 25 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: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Observed Drug Concentration (Cmax) of Dextroamphetamine (d-amphetamine) in Plasma (time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose). The study lists 14 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 18 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.