Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
Condition: Healthy
Intervention: LDX + Venlafaxine XR; Venlafaxine XR + LDX
Intervention description: Day 1-5 LDX 30mg
Day 6-10 LDX 50mg
Day 11-15 LDX 70mg
Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily
Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily
Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily
Day 31-34 Venlafaxine XR 150mg daily
Day 35-38 Venlafaxine XR 75mg daily.; Day 1-5 Venlafaxine XR 75mg
Day 6-10 Venlafaxine XR 150mg
Day 11-15 Venlafaxine XR 225mg
Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily
Day 21-25 Venlafaxine XR and LDX 50mg daily
Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily
Day 31-34 Venlafaxine XR 150mg
Day 35-38 Venlafaxine XR 75mg.
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Venlafaxine Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.