Clincosm LogoSign in Get a demo

A Study of LY3314814 in Participants With Liver Impairment

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03499041
Collaborator
AstraZeneca (Industry)
0
Enrollment
4
Locations
4
Arms
6
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3314814 Control

LY3314814 administered orally to participants with normal hepatic function

Drug: LY3314814
Administered orally
Experimental: LY3314814 Mild

LY3314814 administered orally to participants with mild hepatic impairment

Drug: LY3314814
Administered orally
Experimental: LY3314814 Moderate

LY3314814 administered orally to participants with moderate hepatic impairment

Drug: LY3314814
Administered orally
Experimental: LY3314814 Severe

LY3314814 administered orally to participants with severe hepatic impairment

Drug: LY3314814
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814 [Baseline through 240 hours after the administration of study drug]

    PK: AUC(0-∞) of LY3314814

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3314814 [Baseline through 240 hours after the administration of study drug]

    PK: Cmax of LY3314814

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
Exclusion Criteria:

  • Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina

  • Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation

  • Have acute unstable neuropsychiatric disease

  • Have active or uncontrolled neurologic disease, or clinically significant head injury

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orange County Research Center Tustin California United States 92780
2 Clinical Pharmacology of Miami Miami Florida United States 33014
3 Orlando Clinical Research Ctr Orlando Florida United States 32809
4 New Orleans Cntr for Clin Res Knoxville Tennessee United States 37920

Sponsors and Collaborators

  • Eli Lilly and Company
  • AstraZeneca

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03499041
Other Study ID Numbers:
  • 16003
  • I8D-MC-AZEJ
First Posted:
Apr 17, 2018
Last Update Posted:
Jun 28, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases

Study Results

No Results Posted as of Jun 28, 2018