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Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

NCT01096680 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2021-06-14

Study results available
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Summary

This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.

Conditions

  • Sleep Deprivation

Interventions

DRUG

SPD489 20 mg

Single oral dose of 20 mg

DRUG

SPD489 50 mg

Single oral dose of 50 mg

DRUG

SPD489 70 mg

Single oral dose of 70 mg

DRUG

Armodafinil

Single oral dose of 250 mg

DRUG

Placebo

Single oral dose

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-05
Primary Completion
2010-07-18
Completion
2010-07-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01096680 on ClinicalTrials.gov