Healthy VolunteersPhase 1NCT01890785

Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

A Phase 1 study testing Lisdexamfetamine Dimesylate in people with Healthy Volunteers, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lisdexamfetamine Dimesylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2013to 22 Aug 2013
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
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
Willingness to comply with any applicable contraceptive requirements fo the protocol and is:
Male, or
Non pregnant, non lactating female
Females must be at least 90 days post partum or nulliparous
Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, and urinalysis.

Show all 11Show fewer

An understanding, ability, and willingness to fully comply with study procedures and restrictions
Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study related procedures
A body mass index between 18.5-30.0kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
A hemoglobin value of >=12.0g/dL at the Screening Visit and on Day -1 of Treatment Period 1.
Ability to swallow a dose of investigational product according to the study conditions.

Who cannot join

Subjects are excluded from the study if any of the following criteria are met at the Screening Visit or at Day 1 of Treatment Period 1 (if reassessed):
Current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy, or other conditions) that could affect the action, absorption, or disposition of the investigational products, or could affect clinical or laboratory assessments.
Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
History of significant anxiety, tension, or agitation as assessed by the investigator.
History of or current diagnosis of glaucoma.

Show all 27Show fewer

History of a seizure disorder (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or known family history of Tourette's Disorder.
History or presence of known structural cardiac abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia.
History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
History of controlled or uncontrolled hypertension or a resting supine systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
Known family history of sudden cardiac death or ventricular arrhythmia.
Currently considered a suicide risk, has previously made a suicide attempt, or has a history of, or is currently demonstrating suicidal ideation.
Current use of any medication (including prescription, over-the-counter, herbal or homeopathic preparations) with the exception of hormonal replacement therapy or hormonal contraceptives (current use is defined as use within 14 days of first dose of investigational product).
Use of any medication known to inhibit or induce the cytochrome P450 (CYP450) enzymes responsible for the metabolism of the investigational product within 14 days of first dose of investigational product.
Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
Known or suspected intolerance or hypersensitivity to orange juice or vanilla yogurt.
History of alcohol or other substance abuse within the last year.
A positive screen for alcohol or drugs of abuse at the Screening Visit or on Day 1 of Treatment Period 1.
Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit=1 beer=1 wine [5oz]=one liquor [1.5 oz]=0.75oz alcohol.).
A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen.
Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to the first dose of investigational product.
Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6oz cup of coffee, two 12oz cans of cola, one 12oz cup of tea, three 1oz chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).
Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the first dose of investigational product.
Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrollment in another drug or vaccine clinical study.
Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the investigator.
An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
Prior screen failure, randomization, participation, or enrollment in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami, Inc
Miami, Florida

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of SPD489 When the Contents Are Emptied Into a Soft Food and Orange Juice in Healthy Adult Subjects

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Conditions: Healthy Volunteers
Being tested: Lisdexamfetamine Dimesylate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lisdexamfetamine DimesylateDrug
Also called SPD489
Single dose of a 70 mg capsule on Day 1

Study groups in NCT01890785
Study group	Role	What they receive
Lisdexamfetamine Dimesylate Fasting	Experimental	lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions Receives: Drug: Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate Vanilla Yogurt	Experimental	Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt Receives: Drug: Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate Orange Juice	Experimental	Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice Receives: Drug: Lisdexamfetamine Dimesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate
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.
Measured: Up to 96 hours post-dose
Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate
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.
Measured: Up to 96 hours post-dose
AUC for D-amphetamine
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Measured: Up to 96 hours post-dose
Cmax for D-amphetamine
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Measured: Up to 96 hours-post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201322 Aug 2013

First posted2 Jul 2013 (estimated)
Study start15 Jul 2013
Primary completion22 Aug 2013
Study completion22 Aug 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01890785
Sponsor's protocol ID: SPD489-123
Status last verified: May 2021
First submitted: 27 Jun 2013
Last updated: 3 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ermer J, Corcoran M, Lasseter K, Martin PT. Relative Bioavailabilities of Lisdexamfetamine Dimesylate and D-Amphetamine in Healthy Adults in an Open-Label, Randomized, Crossover Study After Mixing Lisdexamfetamine Dimesylate With Food or Drink. Ther Drug Monit. 2016 Dec;38(6):769-776. doi: 10.1097/FTD.0000000000000343.
PubMed 27661399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of SPD489 When the Contents Are Emptied Into a Soft Food and Orange Juice in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01890785
Acronym / sponsor ID: SPD489-123
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 15 Jul 2013 (actual)
Primary completion: 22 Aug 2013 (actual)
Study completion: 22 Aug 2013 (actual)
First posted: 2 Jul 2013 (estimated)
Results: Posted 21 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lisdexamfetamine Dimesylate Fasting	Experimental	Drug: Lisdexamfetamine Dimesylatelisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions
Lisdexamfetamine Dimesylate Vanilla Yogurt	Experimental	Drug: Lisdexamfetamine DimesylateLisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt
Lisdexamfetamine Dimesylate Orange Juice	Experimental	Drug: Lisdexamfetamine DimesylateLisdexamfetamine Dimesylate 70mg capsule mixed into orange juice

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
Willingness to comply with any applicable contraceptive requirements fo the protocol and is:
Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, and urinalysis.
An understanding, ability, and willingness to fully comply with study procedures and restrictions
Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study related procedures

Key exclusion criteria (27 listed)

Subjects are excluded from the study if any of the following criteria are met at the Screening Visit or at Day 1 of Treatment Period 1 (if reassessed):
Current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy, or other conditions) that could affect the action, absorption, or disposition of the investigational products, or could affect clinical or laboratory assessments.
Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
History of significant anxiety, tension, or agitation as assessed by the investigator.

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
Lisdexamfetamine DimesylateAlso: SPD489Single dose of a 70 mg capsule on Day 1	Drug	Lisdexamfetamine Dimesylate Fasting, Lisdexamfetamine Dimesylate Orange Juice, Lisdexamfetamine Dimesylate Vanilla Yogurt

Primary outcome

Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate
Time frame: Up to 96 hours post-dose
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.
Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate
Time frame: Up to 96 hours post-dose
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.
AUC for D-amphetamine
Time frame: Up to 96 hours post-dose
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Cmax for D-amphetamine
Time frame: Up to 96 hours-post-dose
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.

Results and safety

Results posted to the registry on 21 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	5	5
Sequence 2	5	5
Sequence 3	5	5
Sequence 4	5	5
Sequence 5	5	5
Sequence 6	5	5

Primary outcome: Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate

Time frame: Up to 96 hours post-dose. Mean (Standard Deviation). Unit: ng*hr/ml

Measure	Lisdexamfetamine Dimesylate Mixed in Orange Juice n = 30	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt n = 30	Lisdexamfetamine Dimesylate Intact Capsule Fasting n = 30
Value	27.0 (7.8)	36.0 (14.2)	38.3 (12.3)

Lisdexamfetamine Dimesylate Mixed in Orange Juice vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.708 (90% CI 0.655 to 0.766)
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.918 (90% CI 0.849 to 0.992)

Population analysed: 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.

Primary outcome: Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate

Time frame: Up to 96 hours post-dose. Mean (Standard Deviation). Unit: ng/ml

Measure	Lisdexamfetamine Dimesylate Mixed in Orange Juice n = 30	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt n = 30	Lisdexamfetamine Dimesylate Intact Capsule Fasting n = 30
Value	24.5 (7.48)	32.2 (11.46)	38.5 (13.07)

Lisdexamfetamine Dimesylate Mixed in Orange Juice vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.641 (90% CI 0.582 to 0.707)
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.828 (90% CI 0.752 to 0.912)

Primary outcome: AUC for D-amphetamine

Time frame: Up to 96 hours post-dose. Mean (Standard Deviation). Unit: ng*h/ml

Measure	Lisdexamfetamine Dimesylate Mixed in Orange Juice n = 30	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt n = 30	Lisdexamfetamine Dimesylate Intact Capsule Fasting n = 30
Value	1140.9 (274.1)	1110.1 (252.9)	1180.2 (295.1)

Lisdexamfetamine Dimesylate Mixed in Orange Juice vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.970 (90% CI 0.937 to 1.004)
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.944 (90% CI 0.912 to 0.977)

Primary outcome: Cmax for D-amphetamine

Time frame: Up to 96 hours-post-dose. Mean (Standard Deviation). Unit: ng/ml

Measure	Lisdexamfetamine Dimesylate Mixed in Orange Juice n = 30	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt n = 30	Lisdexamfetamine Dimesylate Intact Capsule Fasting n = 30
Value	59.1 (9.47)	59.0 (9.28)	61.0 (10.81)

Lisdexamfetamine Dimesylate Mixed in Orange Juice vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.971 (90% CI 0.945 to 0.998)
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt vs Lisdexamfetamine Dimesylate Intact Capsule Fasting: Ratio of geometric least squares means: 0.970 (90% CI 0.944 to 0.997)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lisdexamfetamine Dimesylate Mixed in Orange Juice	0 of 30 (0%)	16 of 30 (53.3%)	Not reported
Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt	0 of 30 (0%)	17 of 30 (56.7%)	Not reported
Lisdexamfetamine Dimesylate Intact Capsule Fasting	0 of 30 (0%)	9 of 30 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27661399Ermer J, Corcoran M, Lasseter K, Martin PT. Relative Bioavailabilities of Lisdexamfetamine Dimesylate and D-Amphetamine in Healthy Adults in an Open-Label, Randomized, Crossover Study After Mixing Lisdexamfetamine Dimesylate With Food or Drink. Ther Drug Monit. 2016 Dec;38(6):769-776. doi: 10.1097/FTD.0000000000000343.

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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

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 Lisdexamfetamine Dimesylate in people with Healthy Volunteers, run by Shire 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 11 inclusion and 27 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 3 Jun 2021. 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 21 Apr 2014). 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?

Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate (time frame: Up to 96 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01890785, which also lists 1 linked publication.

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 3 Jun 2021.