A Study of LY2624803 in Japanese Participants With Transient Insomnia

NCT01784614 | Completed Phase 1 Results

• 2 other identifiers: 12662I2K-JE-ZZAW
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods. Participants will receive a single dose of LY2624803 or placebo in each treatment period.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

• Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo

  WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.

  8 hours in Periods 1, 2 and 3

Secondary Outcomes (4)

• Latency to Persistent Sleep (LPS)

  8 hours in Periods 1, 2 and 3

• Total Sleep Time (TST)

  8 hours in Periods 1, 2 and 3

• PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4

• PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4

Study Arms (5)

0.1 milligrams (mg) LY2624803

EXPERIMENTAL

Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods

Drug: LY2624803 - Solution; Drug: Placebo - Capsule

1.0 mg LY2624803

EXPERIMENTAL

Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods

Drug: LY2624803 - Capsule; Drug: Placebo - Solution

3.0 mg LY2624803

EXPERIMENTAL

Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods

Drug: LY2624803 - Capsule; Drug: Placebo - Solution

6.0 mg LY2624803

EXPERIMENTAL

Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods

Drug: LY2624803 - Capsule; Drug: Placebo - Solution

Placebo

PLACEBO COMPARATOR

Single dose of placebo administered orally in up to 1 of 4 treatment periods

Drug: Placebo - Solution; Drug: Placebo - Capsule

Interventions

LY2624803 - Solution DRUG

Administered orally as reconstituted solution

0.1 milligrams (mg) LY2624803

LY2624803 - Capsule DRUG

Administered orally as a capsule

1.0 mg LY2624803; 3.0 mg LY2624803; 6.0 mg LY2624803

Placebo - Solution DRUG

Administered orally as solution

1.0 mg LY2624803; 3.0 mg LY2624803; 6.0 mg LY2624803; Placebo

Placebo - Capsule DRUG

Administered orally as a capsule

0.1 milligrams (mg) LY2624803; Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy males or female Japanese
• Women of child-bearing potential, who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug
• Body mass index (BMI) of 17.6 to 26.4 kilogram per meter square (kg/m\^2), inclusive
• Normal bedtime hours, with routine time spent in bed between 6.5 hours and 9 hours each night
• Clinical laboratory test results within normal reference range
• Venous access sufficient to allow blood sampling as per the protocol
• Are reliable and willing to make themselves available for the duration of the study and are willing and able to follow study procedures
• Have given written informed consent approved by Lilly and the ethical review board governing the site

You may not qualify if:

• Within 4 months of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
• Persons who have previously completed or withdrawn from this study or any other study investigating LY2624803 after receiving study drug
• Known allergies to LY2624803 or related compounds
• Women who are lactating
• Shift workers \[those who shifted or plan to shift work within 7 days of any phase advance polysomnography (PSG) night\] or any person who has crossed (or will have crossed) more than one time zone by aircraft within 3 days prior to entry
• Have an irregular or altered sleep/wake schedule that is likely to prevent from keeping a regular sleep/wake schedule during the study
• Regular napping (≥ 2 daytime naps/week by history)
• Extreme morning type or evening type
• Rhinitis, conjunctivitis, urticaria or chronic pain severe enough to interfere with sleep
• Nocturia that would interfere with sleep assessment
• Symptoms consistent with a sleep disorder or history of same
• Evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months that could contribute to insomnia
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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
• History or presence of orthostatic signs and symptoms within 2 years
• History of seizure or a close relative having a seizure disorder (such as epilepsy). History of a single febrile convulsion more than 10 years ago is acceptable. History of cranial trauma and loss of consciousness will be discussed prior to including any such participant

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sagamihara, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 28, 2016
• Results First Posted: January 28, 2016

Record last verified: 2015-12

Locations

JP (1)