A Study of LY2409021 in Participants With Different Levels of Kidney Function

NCT01929109 | Completed Phase 1 Results

• 2 other identifiers: 14578I1R-MC-GLBT
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function. There were five study groups. Each participant only enrolled in one group. Participants in groups 1 through 4 were healthy or have mild, moderate, or severe kidney disease. They completed one study period lasting about 29 days. Study group 5 enrolled participants with kidney disease who were on dialysis. They have completed two study periods which together last about 59 days. Screening was required within 21 days prior to the start of the study for all participants.

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021

  Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

• Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021

  Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis

  Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

• Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis

  Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

Study Arms (5)

LY2409021 Control

EXPERIMENTAL

Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.

Drug: LY2409021

LY2409021 Mild Renal Impairment

EXPERIMENTAL

Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.

Drug: LY2409021

LY2409021 Moderate Renal Impairment

EXPERIMENTAL

Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.

Drug: LY2409021

LY2409021 Severe Renal Impairment

EXPERIMENTAL

Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.

Drug: LY2409021

LY2409021 End Stage Renal Disease

EXPERIMENTAL

Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.

Drug: LY2409021

Interventions

LY2409021 DRUG

Administered orally

LY2409021 Control; LY2409021 End Stage Renal Disease; LY2409021 Mild Renal Impairment; LY2409021 Moderate Renal Impairment; LY2409021 Severe Renal Impairment

Eligibility Criteria

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

You may qualify if:

• Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2409021
• Female participants must not be of child-bearing potential
• Participants have a body mass index (BMI) of 18 to 40 kilogram per meter square (kg/m\^2), inclusive, at screening
• \- Control participants must have normal renal function, assessed by mean estimated creatinine clearance (CLcr) greater than or equal to (≥)90 milliliter per minute (mL/min) at screening and day before dosing
• \- Males or females with stable mild-to-severe renal impairment, assessed by estimated CLcr, or with ESRD requiring hemodialysis (or hemodiafiltration) for at least 3 months
• \- Participants with T2DM that are being treated with diet or exercise alone or receive treatment with insulin

You may not qualify if:

• Participants that require peritoneal dialysis
• Participants that have a current, functioning, organ transplant
• Participants who show evidence of significant active uncontrolled endocrine or autoimmune abnormalities (for example, thyroid disease, pernicious anemia) as judged by the screening physician
• Participants who had a febrile illness within 3 days prior to screening
• Participants with an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study. \[Participants with a QT interval corrected using Fridericia's (QTcF) formula \>450 millisecond (msec) or a PR interval \>0.22 sec on the screening ECG, or who have risk factors for Torsades de Pointes\]
• Participants who show evidence of significant active neuropsychiatric disease
• Participants that are currently using or intend to use potent inhibitors of cytochrome P450 (CYP)3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin
• Participants who are currently using drugs with a narrow therapeutic index (for example, digoxin,lithium, phenytoin, theophylline, and warfarin)
• Participants that are currently using drugs that are known to prolong the QT interval
• Participants that have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before LY2409021 administration
• Participants with poorly controlled hypertension (systolic blood pressure (BP) less than (\>)160, diastolic BP \>95 mm Hg) and/or evidence of labile blood pressure including symptomatic postural hypotension
• Participants with hemoglobin \<9 grams per deciliter (g/dL) or significant active hematologic disease from causes other than underlying renal disease
• Participants who use an oral or injectable antihyperglycemic agent, except for insulin, within 1 month prior to dosing (Day 1)
• Participants who have experienced a ketoacidotic episode (pH \<7.3) requiring hospitalization in the last 6 months

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Munich, 81241, 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.

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

adomeglivant

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

One participant who received drug was identified as deviating from the protocol due to having Type 1 Diabetes Mellitus (T1DM) and was discontinued and data are not included in Baseline Characteristics, Outcome Measures or AEs.

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: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-03

Locations

DE (1); GB (1)