Effect of Armodafinil on Simulated Driving

NCT02468856 | Completed Phase 1 FDA Drug

• 2 other identifiers: IRB201500170OCR16236
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer. Sleep deprivation affects quality of life when it causes errors in judgment, whether these occur behind the wheel of an automobile or in a hospital. Armodafinil, a non-amphetamine wakefulness promoting medication, indicated for excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder is used to mitigate the effects of sleep deprivation. This study will characterize the effect of armodafinil on driving simulator performance. The effects of armodafinil compared to placebo will be studied in a double blind crossover trial involving 10 healthy subjects with serial assessments at baseline and after extensive sleep deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated driving and neurocognitive assessments of vigilance, the relationship between brain activity and cognitive performance will be established.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Effect of armodafinil on simulated driving

  Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.

  Change in resting baseline (Day 1) to fatigue baseline (Day 2).

• Electroencephalogram activity assessment change in hours post-dose

  Brain activity will be assessed by the electroencephalogram spectral power in microvolt \^2.

  0, 1, 2, 4, 5, 6, 8, 9 change in hours post-dose

• Driving simulator performance assessment change in hours post-dose

  Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.

  0, 2, 5, 7.5 change in hours post-dose

• Effect of armodafinil on electroencephalogram activity

  Brain activity will be assessed by the electroencephalogram spectral power in microvolt \^2.

  Change in resting baseline (Day 1) to fatigue baseline (Day 2).

• Area under the plasma concentration versus time curve (AUC) of armodafinil 250 mg

  0, 0.5, 1, 1.5, 2, 3, 4, 6, 7.5 and 10 hours post-dose

Secondary Outcomes (16)

• Motor Praxis Task assessment pre-dose

  Change in resting baseline (Day 1) to fatigue baseline (Day 2).

• Motor Praxis Task assessment change in hours post-dose

  1, 4, 6, 9 change in hours post-dose

• Visual Object Learning Test assessment pre-dose

  Change in resting baseline (Day 1) to fatigue baseline (Day 2).

• Visual Object Learning Test assessment change in hours post-dose

  1, 4, 6, 9 change in hours post-dose

• Fractal-2-Back assessment pre-dose

  Change in resting baseline (Day 1) to fatigue baseline (Day 2).

Study Arms (2)

Armodafinil

ACTIVE COMPARATOR

Armodafinil 250 mg tablets, one time administration per study session in the morning of day 2

Drug: armodafinil

Placebo

PLACEBO COMPARATOR

one time administration per study session in the morning of day 2

Drug: Placebo (for armodafinil)

Interventions

armodafinil DRUG

Armodafinil 250 mg tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Area under the plasma concentration versus time curve (AUC), Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test

Also known as: Nuvigil

Armodafinil

Placebo (for armodafinil) DRUG

Placebo tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or females, between age 18 and 35 years of age, inclusive.
• Body mass index (BMI) from 18.5 to 29.9 kg/m2, inclusive.
• A valid driver's license.
• Healthy on the basis of physical examination, medical history, vital signs.
• Absence of clinically significant abnormalities in the subject's sleep history. The study physician will base this decision on the Epworth Sleepiness Scale and a discussion with the subject about his or her sleep history.
• Female subjects must be postmenopausal (for at least 6 months), surgically sterile, or abstinent; or, if of childbearing potential and sexually active, be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at screening, and a negative urine pregnancy test prior to each experimental session. Steroidal contraceptives have been shown to interact with the study drug and are not an acceptable form of contraception for this study (subjects taking steroidal contraceptive drugs are ineligible for this study).
• Agree not to consume any alcohol 24 hours prior to any study session and until discharge from the unit.
• Agree not to consume any grapefruit or grapefruit juice 24 hours prior to dosing and until discharge from the unit.
• Agree not to use armodafinil or modafinil-containing medications 2 weeks prior to or during any study session (aside from what is administered for the study).
• Agree not to use any other medication that acts on the central nervous system (prescription or nonprescription) 1 week prior to or during any study session (caffeine is the only exception, subjects are recommended to avoid caffeine for one week prior to a study session, but are required to avoid caffeine for 24 hours prior to and during a study session).
• The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Subject is willing to provide informed consent.

You may not qualify if:

• History of current significant medical illness including (but not limited to) cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, psychiatric disorders, or any other illness that the investigator considers should exclude the subject.
• Subjects who have a clinically significant sleep abnormality.
• Subjects who are shift workers.
• Evidence of use of drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) assessed via questioning the subject.
• Subjects that are a smoker and smoke more than 10 cigarettes per day.
• Known allergies or hypersensitivity to armodafinil or modafinil.
• The subject has contraindications to take armodafinil.
• Clinically significant abnormal physical examination, vital signs (e.g. systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg, heart rate \>100 bpm and \<45 bpm) or 12-lead ECG (e.g. corrected QT\>450 msec) at screening or abnormal vital signs prior to study drug dosing.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Pregnant or breast-feeding.
• Taking a steroidal contraceptive drug or drugs.
• Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration.
• Recent history of surgery; within the past 3 months prior to screening.
• Clinically significant acute illness within 7 days prior to study drug administration.
• Strenuous exercise that is more excessive than their normal routine, 48 hours prior to each session, until they are discharged from the unit.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida, Clinical and Translational Science Institute

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hartmut Derendorf, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 11, 2015
• Study Start: May 21, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: December 31, 2018

Record last verified: 2018-12

Locations

US (1)