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

• Conditions: insomnia; sleep disorders; 10040991

• Registration Number: NL-OMON31867
• Lead Sponsor: Eli Lilly

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

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
disorder.
5.Insomnia caused by a psychiatric, neurological or medical disease within the past
12 months.
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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the cognitive and psychomotoric effects of LY2624803,<br /><br>diphenhydramine and zolpidem after bedtime dosing in healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Determine the cognitive and psychomotor effects of LY2624803 at 5 and 8 hours<br /><br>post-evening dose (after a first awakening at 2 hours post dose) on periods 1-4<br /><br>-Determine the cognitive and psychomotor effects of LY2624803 at 5 and 8 hours<br /><br>post-evening dose (after a first awakening at 5 hours post dose) on period 5<br /><br>-Explore the relationship between the cognitive and psychomotor tests and<br /><br>LY2624803, zolpidem and diphenhydramine doses and exposures.</p><br>