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Clinical Trials/NL-OMON31867
NL-OMON31867Not yet recruitingNot Applicable

Evaluation of the cognitive and psychomotor effects of LY2624803 following bedtime dosing in healthy subjects - Evaluation of CNS effects of LY2624803 following bedtime dosing

Eli Lilly0 sites40 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Eli Lilly
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Provision of written informed consent
  • •2. Healthy male and female subjects aged 18 to 45 years or 65-85 years on sceening
  • •3. Body Mass Index (BMI) >= 19 and <= 30 kg/m2

Exclusion Criteria

  • •1.Investigator site personnel or Lilly employees directly affiliated with this study
  • •and their immediate families. Immediate family is defined as a spouse, parent,
  • •child or sibling, whether biological or legally adopted.
  • •2.Shift workers (those who shifted work within 7 days of any study night) or any
  • •person who has crossed (or will have crossed) more than one time zone by aircraft
  • •within 3 days prior to each study night.
  • •3.Rhinoconjunctivitis, urticaria, chronic pain or nocturia that, in the investigator*s
  • •opinion, would interfere with sleep assessment.
  • •4.Previously diagnosed sleep disorder including chronic insomnia, sleep apnea,
  • •narcolepsy or restless leg syndrome, or current symptoms consistent with a sleep
  • •5.Insomnia caused by a psychiatric, neurological or medical disease within the past
  • •6.Irregular or altered sleep/wake schedule interpreted by the investigator.
  • •7.History of loss of consciousness due to explained or unexplained syncope or
  • •orthostatic signs and symptoms such as dizziness, tachycardia or hypotension.
  • •History of loss of consciousness due to cranial trauma will be discussed prior to
  • •including any such subject (See Section 6.4.1.3 for orthostatic measurement
  • •procedure).
  • •8.Known history of epilepsy (except a single febrile convulsion) or a family history
  • •of seizures.
  • •9.Use of prescription, over the counter or herbal medications (other than oral
  • •contraceptive treatment or hormonal replacement therapy) that can safely be
  • •discontinued within 21 days prior to enrollment. Subjects over 65 yrs of age, on a
  • •stable dose (>= 3 months prior to screening) of one medication for lowering
  • •cholesterol, triglycerides and/or one medication for lowering blood pressure
  • •and/or substitutive hormonal therapy in post menopausal women are allowed
  • •provided those treatments have no clinically significant central nervous system
  • •adverse effects. See Section 5.6 Concomitant Therapy, for sample list of
  • •acceptable medication.
  • •10.Enrolment in another concurrent investigational study or intake of an
  • •investigational drug within 3 months prior to the start of the study or more than 4
  • •times a year.
  • •11. Known allergies or contraindications to LY2624803, zolpidem, diphenhydramine
  • •or related compounds.
  • •12.Persons who have previously completed or withdrawn from this study or any
  • •other study investigating LY2624803 or HY10275
  • •13.An abnormality in the 12-lead ECG that, in the opinion of the investigator,
  • •increases the risks associated with participating in the study.
  • •14.History or presence of clinically significant cardiovascular, respiratory, hepatic,
  • •renal, gastrointestinal, endocrine, haematological, neurocardiogenic or
  • •neurological disorders capable of significantly altering the absorption,
  • •metabolism, or elimination of drugs; of constituting a risk when taking the study
  • •medication; or of interfering with the interpretation of data.
  • •15.Any other condition which in the opinion of the investigator would preclude
  • •participation the study.
  • •16.Current regular use (including recreational uses) of any illicit drugs (including
  • •cannabis) confirmed by positive urine drug screen at screening or any study day,
  • •or a history of drug or alcohol abuse.
  • •17.Positive Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C test.
  • •18.Women who are lact

Investigators

Sponsor
Eli Lilly

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