Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01235338
First received: November 2, 2010
Last updated: March 27, 2013
Last verified: March 2013
Results First Received: November 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: LDX + Venlafaxine XR
Drug: Venlafaxine XR + LDX

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 80 randomized subjects, 3 did not receive any investigational product and therefore were not included in the Safety Analysis/Pharmacokinetic Analysis Sets (n = 77).

Reporting Groups
  Description
LDX + Venlafaxine XR LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR + LDX Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.

Participant Flow:   Overall Study
    LDX + Venlafaxine XR     Venlafaxine XR + LDX  
STARTED     42     38  
COMPLETED     31     33  
NOT COMPLETED     11     5  
Adverse Event                 3                 2  
Protocol Violation                 1                 1  
Withdrawal by Subject                 5                 0  
Exclusion criteria violations                 1                 1  
Positive drug screen                 0                 1  
Prohibited meds                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LDX + Venlafaxine XR LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR + LDX Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Total Total of all reporting groups

Baseline Measures
    LDX + Venlafaxine XR     Venlafaxine XR + LDX     Total  
Number of Participants  
[units: participants]
  40     37     77  
Age [1]
[units: years]
Mean ± Standard Deviation
  33.2  ± 7.01     33.8  ± 7.29     33.5  ± 7.10  
Age, Customized  
[units: participants]
     
Between 18 and 45 years     40     37     77  
Gender  
[units: participants]
     
Female     12     10     22  
Male     28     27     55  
Region of Enrollment  
[units: participants]
     
United States     40     37     77  
[1] The Safety Analysis Set (n = 77) was used to calculate Baseline Measures. The Safety Analysis Set is defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. 80 subjects were enrolled but 3 never received investigational product.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

2.  Primary:   Cmax of d-Amphetamine   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

3.  Primary:   Cmax of Venlafaxine Hydrochloride   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

4.  Primary:   Cmax of o-Desmethylvenlafaxine   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

5.  Primary:   Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

6.  Primary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

7.  Primary:   AUC of d-Amphetamine   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

8.  Primary:   AUC of Venlafaxine Hydrochloride   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

9.  Primary:   AUC of o-Desmethylvenlafaxine   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

10.  Primary:   AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

11.  Primary:   Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

12.  Primary:   Tmax of d-Amphetamine   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

13.  Primary:   Tmax of Venlafaxine Hydrochloride   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

14.  Primary:   Tmax of o-Desmethylvenlafaxine   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

15.  Primary:   Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)   [ Time Frame: Day 15 and Day 30 (24 hour sampling) ]

16.  Secondary:   Systolic Blood Pressure   [ Time Frame: Baseline and up to 39 days ]

17.  Secondary:   Diastolic Blood Pressure   [ Time Frame: Baseline and up to 39 days ]

18.  Secondary:   Pulse Rate   [ Time Frame: Baseline and up to 39 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Patrick Martin, MD
Organization: Shire Pharmaceutical
e-mail: pmartin@shire.com


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01235338     History of Changes
Other Study ID Numbers: SPD489-117
Study First Received: November 2, 2010
Results First Received: November 4, 2011
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration