Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: LDX + Venlafaxine XR (Drug); Venlafaxine XR + LDX (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Shire
Summary
This study will examine the effects of co-administration of SPD489 and the antidepressant
EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In
addition, serial blood pressure and pulse measures will be obtained and examined to ensure
that there are no unexpected changes in vital signs following co administration of SPD489
and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis
is that a drug drug interaction could possibly exist.
Clinical Details
Official title: A Phase 1, Open-label, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD489 and EFFEXOR XR, Administered Alone and in Combination in Healthy Adult Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine DimesylateCmax of d-Amphetamine Cmax of Venlafaxine Hydrochloride Cmax of o-Desmethylvenlafaxine Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine) Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate AUC of d-Amphetamine AUC of Venlafaxine Hydrochloride AUC of o-Desmethylvenlafaxine AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine) Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate Tmax of d-Amphetamine Tmax of Venlafaxine Hydrochloride Tmax of o-Desmethylvenlafaxine Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Secondary outcome: Systolic Blood PressureDiastolic Blood Pressure Pulse Rate
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18-45 years
2. Subject is willing to comply with any applicable contraceptive requirements of the
protocol and is:
- Male, or
- Non-pregnant, non-lactating female
- Females must be at least 90 days post partum or nulliparous.
3. Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG)
pregnancy test
4. Satisfactory medical assessment
5. Ability to provide information on family history of hypertension.
6. Body Mass Index (BMI) between 18. 5 and 30. 0kg/m² inclusive.
7. Ability to swallow all investigational products.
Exclusion Criteria:
1. Current or recurrent disease (e. g., cardiovascular, renal, liver, gastrointestinal,
malignancy or other conditions)
2. Current or relevant previous history of physical or psychiatric illness.
3. Significant illness.
4. History of significant anxiety, tension, or agitation as assessed by the
Investigator.
5. History of or current diagnosis of glaucoma.
6. 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.
7. 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.
8. History of controlled or uncontrolled hypertension or a resting sitting systolic BP
>139mmHg or diastolic BP >89mmHg.
9. Known family history of sudden cardiac death or ventricular arrhythmia.
10. Suicidal ideation or any lifetime history of suicidal behavior.
11. Consumption of alcohol, Seville oranges, grapefruit, or any grapefruit containing
products within 7 days of first dose of investigational product.
12. Current use of any medication (including prescription, over the counter [OTC], herbal
or homeopathic preparations or supplements) with the exception of the occasional dose
of acetaminophen, or hormonal contraceptives.
13. History of alcohol or other substance abuse within the last year.
14. A positive screen for alcohol or drugs of abuse.
15. Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
Female subjects who consume more than 14 units of alcohol per week or 2 units per
day. [1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1. 5oz) = 0. 75oz alcohol]
16. A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface
antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen.
17. Use of tobacco in any form (e. g., smoking or chewing) or other nicotine-containing
products in any form (e. g. gum, patch). Ex-users must report that they have stopped
using tobacco for at least 30 days prior to receiving the first dose of
investigational product.
18. Routine consumption of more than 2 units of caffeine per day or subjects who
experience 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, or one 8oz. serving of an energy drink. Decaffeinated
coffee, tea, or cola are not considered to contain caffeine).
19. Donation of blood or blood products (e. g., plasma or platelets) within 60 days prior
to receiving the first dose of investigational product.
Locations and Contacts
Clinical Pharmacology of Miami, Miami, Florida 33014, United States
Additional Information
FDA Recall Information FDA-approved label
Starting date: November 2010
Last updated: March 27, 2013
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