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

NCT01890785 | Completed Phase 1 Results

• 1 other identifier: SPD489-123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 96 hours-post-dose

Study Arms (3)

Lisdexamfetamine Dimesylate Fasting

EXPERIMENTAL

lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions

Drug: Lisdexamfetamine Dimesylate

Lisdexamfetamine Dimesylate Vanilla Yogurt

EXPERIMENTAL

Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt

Drug: Lisdexamfetamine Dimesylate

Lisdexamfetamine Dimesylate Orange Juice

EXPERIMENTAL

Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice

Drug: Lisdexamfetamine Dimesylate

Interventions

Lisdexamfetamine Dimesylate DRUG

Single dose of a 70 mg capsule on Day 1

Also known as: SPD489

Lisdexamfetamine Dimesylate Fasting; Lisdexamfetamine Dimesylate Orange Juice; Lisdexamfetamine Dimesylate Vanilla Yogurt

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Clinical Pharmacology of Miami, Inc

Miami, Florida, United States

Location

Related Publications (1)

• 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.

  PMID: 27661399 RESULT

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: July 15, 2013
• Primary Completion: August 22, 2013
• Study Completion: August 22, 2013
• Last Updated: June 3, 2021
• Results First Posted: April 21, 2014

Record last verified: 2021-05

Locations

US (1)