A Study to Evaluate the Pharmacokinetics of LY2624803 in Subjects With Hepatic Impairment

NCT01257178 | Terminated Phase 1

• 2 other identifiers: 12809I2K-MC-ZZBL
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the impact of hepatic dysfunction on the pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

• LY2624803 and the metabolite LSN2797276 Area under the Curve from time 0 to infinity [AUC(0-∞)]

  Predose through 120 hours post dose

• LY2624803 and the metabolite LSN2797276, Maximum Concentration (Cmax)

  Predose through 120 hours post dose

• LY2624803 and the metabolite LSN2797276, Time to maximum plasma concentration(tmax)

  Predose through 120 hours post dose

Secondary Outcomes (6)

• LY2624803 and the metabolite LSN2797276, Elimination half live (t1/2)

  Predose through 120 hours post dose

• LY2624803 and the metabolite LSN2797276, AUC to the last quantifiable sample [AUC(0-tlast)]

  Predose through 120 hours post dose

• LY2624803 and the metabolite LSN2797276, Apparent clearance (CL/F)

  Predose through 120 hours post dose

• LY2624803 and the metabolite LSN2797276, Apparent volume of distribution (V/F)

  Predose through 120 hours post dose

• LY2624803 and the metabolite LSN2797276, Parent to metabolite ratios (MR) of Cmax

  Predose through 120 hours post dose

Study Arms (4)

Normal hepatic function

EXPERIMENTAL

6mg, oral, once on day 1

Drug: LY2624803

Mild hepatic impairment

EXPERIMENTAL

6 mg, oral, once on day 1

Drug: LY2624803

Moderate hepatic impairment

EXPERIMENTAL

6 mg, oral, once on day 1

Drug: LY2624803

Severe hepatic impairment

EXPERIMENTAL

6 mg, oral, once on day 1

Drug: LY2624803

Interventions

LY2624803 DRUG

Administered orally

Mild hepatic impairment; Moderate hepatic impairment; Normal hepatic function; Severe hepatic impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Subjects
• Sexually active male and female subjects and their partners must agree to use 2 methods of contraception such as condom or occlusive cap (diaphragm or cervical/vault caps) together with spermicidal foam/gel/film/cream/suppository, from the time the subject enters the study until 3 months after the final dosing occasion, unless the male subject or partner has been sterilized (with confirmed azoospermia).
• Have a BMI between 18.5 and 35.0 kg/m2, inclusive.
• Have a body weight \>50 kg.
• Have normal sitting blood pressure and heart rate compatible with their disease state, as determined by the investigator.
• Have 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 to follow study procedures.
• Have given written informed consent approved by Lilly and the Ethical Review Board governing the site.
• Control Subjects
• Are males or females and with normal hepatic function, as determined by medical history and physical examination.
• Have clinical laboratory test results within normal reference range for the investigator site, or results with minor deviations not considered to be clinically significant by the investigator.
• Hepatic Impaired Subjects
• Have stable hepatic impairment (alcoholic, posthepatitis, biliary cirrhosis, cryptogenic) classified as Child-Pugh class A, B, or C (mild, moderate, and severe impairment) who are considered acceptable for participation in the study by the investigator.

You may not qualify if:

• All Subjects
• Are currently enrolled in, or discontinued within the last 90 days from the last dosing occasion in a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have known allergies to LY2624803 or related compounds.
• Have previously discontinued from this study or any other study investigating LY2624803.
• Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk associated with participating in the study.
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
• Show evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies.
• Have donated blood of more than 500 mL within the last 3 months prior to the screening visit.
• Use drugs or herbal remedies that are known inhibitors or inducers of CYP3A4 or inhibitors of CYP2D6 enzyme pathways, unless in the opinion of the sponsor and investigator the medication will not compromise safety.
• Are liver transplant subjects or have taken immunosuppressants following any organ transplant.
• Have shown signs of variceal bleeding during the last 2 weeks prior to screening.
• Show evidence of irritable bowel syndrome or chronic diarrhea.
• Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), and are subjects unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
• Are unable to swallow whole capsules.
• Are on total parenteral nutrition (TPN).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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.

Mitte, Germany

Location

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.

München, Germany

Location

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.

Debrecen, Hungary

Location

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.

Moscow, Russia

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 9, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 3, 2011

Record last verified: 2011-06

Locations

RU (1); HU (1); DE (2)