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

NCT01235338 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-06-14

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

LDX + Venlafaxine XR

* 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.

DRUG

Venlafaxine XR + LDX

* 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.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-28
Primary Completion
2010-12-30
Completion
2011-01-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235338 on ClinicalTrials.gov