| Primary | Maximum Plasma Drug Concentration (Cmax) Occurred at the Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Plasma Dextroamphetamine (d-Amphetamine) and Plasma Levoamphetamine (l-Amphetamine) | Maximum plasma drug concentration occurred at time of maximum observed concentration of plasma d-amphetamine and plasma l-amphetamine during a dosing interval were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | Pharmacokinetic (PK) set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
| | | Title | Denominators | Categories |
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| d-Amphetamine | | | | l-Amphetamine | | |
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| Primary | Trough Plasma Drug Concentration Ctrough at Steady State (Ctrough,ss) of Plasma d-Amphetamine and Plasma l-Amphetamine | Trough plasma drug concentration (predose concentrations collected at steady state) of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose on Day 1 and Day 28 and at 24 hours (Day 29) postdose on Day 28 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Time to Reach Maximum Observed Plasma Drug Concentration (Tmax) During Dosing Interval of Plasma d-Amphetamine and Plasma l-Amphetamine | Time to reach maximum observed plasma drug concentration of plasma d-amphetamine and plasma l-amphetamine during a dosing interval were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one post-dose PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Median | Full Range | hour | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Area Under the Concentration-Time Curve From Time Zero to the Last Timepoint (AUC0-t) During Sample Collection of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration-time curve from time zero to the last quantifiable concentration of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (hr*ng/mL) | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Area Under the Concentration-Time Curve From Time Zero Predose to Five Hours Postdose (AUC0-5) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration time curve from time zero predose to five hours postdose of plasma d-amphetamine and plasma d-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one post-dose PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: Predose, 2, 5 hours Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Area Under the Concentration Time Curve From Time Five Hours to the Last Timepoint (AUC5-t) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration time curve from time five hours to the time of last quantifiable concentration of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Area Under the Concentration-Time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration-time curve from time of dosing to the last measurable concentration of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Area Under the Concentration-Time Curve Over the Dosing Interval (24 Hours) at Steady State (AUCtau,ss) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration-time curve over the dosing interval (24 hours) at steady state of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Terminal Rate Constant (Lambda z) of Plasma d-Amphetamine and Plasma l-Amphetamine | Terminal Rate Constant of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | per hour | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Total Body Clearance (CL/F) for Extravascular Administration of Plasma d-Amphetamine and Plasma l-Amphetamine | Apparent total clearance of the plasma drug concentration of plasma d- amphetamine and plasma l-amphetamine after oral dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/hr) | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Terminal Half-life (t1/2) of Plasma d-Amphetamine and Plasma l-Amphetamine | Time required for the plasma drug concentration to reach half of its original value of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Median | Full Range | hour | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Apparent Volume of Distribution (Vss/F) at Steady State of Plasma d-Amphetamine and Plasma l-Amphetamine | Apparent volume of distribution at steady state of plasma d-amphetamine and plasma l-amphetamine after oral dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected.Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter | | Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product (IP) and no later than 3 days following the last dose of IP. | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (up to 5 weeks) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs | Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any change in vital signs which were deemed clinically significant by the investigator were recorded as TEAE. | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (up to 5 weeks) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs | 12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE. | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (up to 5 weeks) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Change From Baseline in Height at Final On-Treatment Assessment | Height (in centimeters) was measured using a stadiometer with the participant standing on a flat surface without shoes and with the chin parallel to the floor. Final on-treatment assessment (FoTA) was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | centimeter (cm) | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Change From Baseline in Weight at Final On-Treatment Assessment | Weight (in kilograms) was measured using a calibrated scale. Participant should be in light clothes and without shoes. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Mean | Standard Deviation | kilogram (kg) | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs | Clinical laboratory tests included biochemistry, endocrinology, hematology and urinalysis. Any change in clinical laboratory results which are deemed clinically significant by the investigator were reported as TEAE. | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (up to 5 weeks) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Number of Participants With Overall Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. The assessment was done by the nature of the responses, not by a numbered scale. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Count of Participants | | Participants | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Length of Time Awake Per Night Assessed by PSQ at Final On-Treatment Assessment | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | minutes | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Length of Time to Fall Asleep Per Night Assessed by PSQ at Final On-Treatment Assessment | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Mean | Standard Deviation | minutes | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Length of Time Sleeping Per Night Assessed by PSQ at Final On-Treatment Assessment | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Mean | Standard Deviation | hours | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment | The CSHQ was a validated, retrospective, parent-reported sleep screening tool. The questionnaire consisted of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. A negative value indicated less sleep disturbance. | Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Posted | | Mean | Standard Deviation | Units on scale | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Primary | Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Final On-Treatment Assessment | C-SSRS was a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts (suicidal ideation) and suicidal behaviors during the assessment period needed to be determine if a suicide-related thought or behavior were occurred. The assessment was done by the nature of the responses, not by a numbered scale. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date). | Safety Set consisted of all enrolled participants who had taken at least one dose of investigational product. | Posted | | Count of Participants | | Participants | | FoTA (up to Day 30) | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Secondary | Observed Analyte Concentration at 12 Hours After Dose Administration (C12) of Plasma d-Amphetamine and Plasma l-Amphetamine | Observed analyte concentration of plasma d-amphetamine and plasma l-amphetamine at 12 hours after dose administration were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 4: 12 hours (Day 8) Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Secondary | Observed Analyte Concentration at 16 Hours After Dose Administration (C16) of Plasma d-Amphetamine and Plasma l- Amphetamine | Observed analyte concentration of plasma d-amphetamine and plasma l-amphetamine at 16 hours after dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 4: 16 hours (Day 8) Postdose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Secondary | Observed Analyte Concentration at 24 Hours After Dose Administration (C24) of Plasma d-Amphetamine and Plasma l- Amphetamine | Observed analyte concentration of plasma d-amphetamine and plasma l-amphetamine at 24 hours after dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 4: 24 hours (Day 8) Postdose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Secondary | Area Under the Concentration-Time Curve From Time Five Hours to Twelve Hours Postdose (AUC5-12) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration-time curve from time five hours to twelve hours postdose (AUC5-12) in plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: 5, 8, 12 hours Postdose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Secondary | Area Under the Concentration-Time Curve From Time Twelve Hours to Sixteen Hours Postdose (AUC12-16) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration-time curve from time twelve hours to sixteen hours postdose (AUC12-16) in plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: 12, 16 hours Postdose on Day 7 | | | | ID | Title | Description |
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| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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| Secondary | Area Under the Concentration-Time Curve From Time Sixteen Hours to Twenty-Four Hours Postdose (AUC16-24) of Plasma d-Amphetamine and Plasma l-Amphetamine | Area under the concentration-time curve from time sixteen hours to twenty-four hours postdose (AUC16-24) in plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained. | PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Week 4: 16, 24 hours (Day 8) Postdose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | SHP465 | Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks. |
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