NCT01235338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2010

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2011

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 8, 2011

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

November 2, 2010

Results QC Date

November 4, 2011

Last Update Submit

June 8, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

  • Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate

    Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.

    Day 15 and Day 30 (24 hour sampling)

  • Cmax of d-Amphetamine

    d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.

    Day 15 and Day 30 (24 hour sampling)

  • Cmax of Venlafaxine Hydrochloride

    Venlafaxine Hydrochloride is the active ingredient of Effexor XR

    Day 15 and Day 30 (24 hour sampling)

  • Cmax of o-Desmethylvenlafaxine

    Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.

    Day 15 and Day 30 (24 hour sampling)

  • Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)

    Day 15 and Day 30 (24 hour sampling)

  • Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate

    Day 15 and Day 30 (24 hour sampling)

  • AUC of d-Amphetamine

    Day 15 and Day 30 (24 hour sampling)

  • AUC of Venlafaxine Hydrochloride

    Day 15 and Day 30 (24 hour sampling)

  • AUC of o-Desmethylvenlafaxine

    Day 15 and Day 30 (24 hour sampling)

  • AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)

    Day 15 and Day 30 (24 hour sampling)

  • Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate

    Day 15 and Day 30 (24 hour sampling)

  • Tmax of d-Amphetamine

    Day 15 and Day 30 (24 hour sampling)

  • Tmax of Venlafaxine Hydrochloride

    Day 15 and Day 30 (24 hour sampling)

  • Tmax of o-Desmethylvenlafaxine

    Day 15 and Day 30 (24 hour sampling)

  • Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)

    Day 15 and Day 30 (24 hour sampling)

Secondary Outcomes (3)

  • Systolic Blood Pressure

    Baseline and up to 39 days

  • Diastolic Blood Pressure

    Baseline and up to 39 days

  • Pulse Rate

    Baseline and up to 39 days

Study Arms (2)

LDX (SPD489) + Venlafaxine XR (Effexor XR)

EXPERIMENTAL
Drug: LDX + Venlafaxine XR

Venlafaxine XR + LDX

EXPERIMENTAL
Drug: Venlafaxine XR + LDX

Interventions

LDX + Venlafaxine XRDRUG

* 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.

Also known as: Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489; Venlafaxine hydrochloride extended-release, Effexor XR,
LDX (SPD489) + Venlafaxine XR (Effexor XR)
Venlafaxine XR + LDXDRUG

* 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.

Also known as: Venlafaxine hydrochloride extended-release, Effexor XR; Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489
Venlafaxine XR + LDX

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45 years
  • 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.
  • Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
  • Satisfactory medical assessment
  • Ability to provide information on family history of hypertension.
  • Body Mass Index (BMI) between 18.5 and 30.0kg/m² inclusive.
  • Ability to swallow all investigational products.

You may not qualify if:

  • Current or recurrent disease (e.g., cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions)
  • Current or relevant previous history of physical or psychiatric illness.
  • Significant illness.
  • 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 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.
  • History of controlled or uncontrolled hypertension or a resting sitting systolic BP \>139mmHg or diastolic BP \>89mmHg.
  • Known family history of sudden cardiac death or ventricular arrhythmia.
  • Suicidal ideation or any lifetime history of suicidal behavior.
  • Consumption of alcohol, Seville oranges, grapefruit, or any grapefruit containing products within 7 days of first dose of investigational product.
  • 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.
  • History of alcohol or other substance abuse within the last year.
  • A positive screen for alcohol or drugs of abuse.
  • 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. \[1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1.5oz) = 0.75oz alcohol\]
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Related Publications (1)

  • Ermer J, Haffey MB, Richards C, Lasseter K, Roesch B, Purkayastha J, Corcoran M, Harlin B, Martin P. An open-label investigation of the pharmacokinetic profiles of lisdexamfetamine dimesylate and venlafaxine extended-release, administered alone and in combination, in healthy adults. Clin Drug Investig. 2013 Apr;33(4):243-54. doi: 10.1007/s40261-013-0073-1.

    PMID: 23512639RESULT

Related Links

MeSH Terms

Interventions

Lisdexamfetamine DimesylateVenlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsCyclohexanolsHexanolsFatty AlcoholsAlcoholsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 5, 2010

Study Start

October 28, 2010

Primary Completion

December 30, 2010

Study Completion

January 17, 2011

Last Updated

June 14, 2021

Results First Posted

December 8, 2011

Record last verified: 2021-06

Locations

US(1)