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

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

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
Overall Participants Analyzed  [Units: Participants]	40	37	77
Age [1]  [Units: Years] Mean (Standard Deviation)	33.2  (7.01)	33.8  (7.29)	33.5  (7.10)
[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.
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.  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 ]

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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