Trial Outcomes & Findings for Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers (NCT NCT01890785)
NCT ID: NCT01890785
Last Updated: 2021-06-03
Results Overview
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Up to 96 hours post-dose
Results posted on
2021-06-03
Participant Flow
Participant milestones
| Measure |
Sequence 1
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
|
Sequence 2
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
|
Sequence 3
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
|
Sequence 4
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
|
Sequence 5
Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
|
Sequence 6
Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
First Intervention
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Second Intervention
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Third Intervention
COMPLETED
|
5
|
4
|
5
|
5
|
5
|
5
|
|
Third Intervention
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
|
Sequence 2
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
|
Sequence 3
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
|
Sequence 4
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
|
Sequence 5
Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
|
Sequence 6
Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
|
|---|---|---|---|---|---|---|
|
Third Intervention
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Sequence 1
n=5 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
|
Sequence 2
n=5 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
|
Sequence 3
n=5 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
|
Sequence 4
n=5 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
|
Sequence 5
n=5 Participants
Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
|
Sequence 6
n=5 Participants
Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.6 Years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
35.4 Years
STANDARD_DEVIATION 12.42 • n=7 Participants
|
42.2 Years
STANDARD_DEVIATION 4.44 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 12.42 • n=4 Participants
|
39.6 Years
STANDARD_DEVIATION 9.86 • n=21 Participants
|
41.8 Years
STANDARD_DEVIATION 10.06 • n=10 Participants
|
37.6 Years
STANDARD_DEVIATION 10.07 • n=115 Participants
|
|
Age, Customized
Between 18 and 65 years, inclusive
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Region of Enrollment
UNITED STATES
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 96 hours post-dosePopulation: Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate Mixed in Orange Juice
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Intact Capsule Fasting
n=30 Participants
Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate
|
27.0 ng*hr/ml
Standard Deviation 7.8
|
36.0 ng*hr/ml
Standard Deviation 14.2
|
38.3 ng*hr/ml
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: Up to 96 hours post-dosePopulation: Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate Mixed in Orange Juice
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Intact Capsule Fasting
n=30 Participants
Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate
|
24.5 ng/ml
Standard Deviation 7.48
|
32.2 ng/ml
Standard Deviation 11.46
|
38.5 ng/ml
Standard Deviation 13.07
|
PRIMARY outcome
Timeframe: Up to 96 hours post-dosePopulation: Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate Mixed in Orange Juice
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Intact Capsule Fasting
n=30 Participants
Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
|
|---|---|---|---|
|
AUC for D-amphetamine
|
1140.9 ng*h/ml
Standard Deviation 274.1
|
1110.1 ng*h/ml
Standard Deviation 252.9
|
1180.2 ng*h/ml
Standard Deviation 295.1
|
PRIMARY outcome
Timeframe: Up to 96 hours-post-dosePopulation: Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate Mixed in Orange Juice
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt
n=30 Participants
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Intact Capsule Fasting
n=30 Participants
Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
|
|---|---|---|---|
|
Cmax for D-amphetamine
|
59.1 ng/ml
Standard Deviation 9.47
|
59.0 ng/ml
Standard Deviation 9.28
|
61.0 ng/ml
Standard Deviation 10.81
|
Adverse Events
Lisdexamfetamine Dimesylate Mixed in Orange Juice
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Lisdexamfetamine Dimesylate Intact Capsule Fasting
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate Mixed in Orange Juice
n=30 participants at risk
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt
n=30 participants at risk
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1)
|
Lisdexamfetamine Dimesylate Intact Capsule Fasting
n=30 participants at risk
Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
3/30 • Number of events 3
|
16.7%
5/30 • Number of events 5
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.0%
9/30 • Number of events 9
|
26.7%
8/30 • Number of events 8
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
13.3%
4/30 • Number of events 4
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER