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Trial record 1 of 27 for:    Edivoxetine OR LY2216684
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A Study of LY2216684 in Participants With Impaired Hepatic Function

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ClinicalTrials.gov Identifier: NCT01241435
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Intervention Drug: LY2216684
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Hide Arm/Group Description LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
Period Title: Overall Study
Started 12 8 8 8
Received at Least 1 Dose of Study Drug 12 8 8 8
Completed 12 8 8 8
Not Completed 0 0 0 0
Arm/Group Title Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment Total
Hide Arm/Group Description LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C) Total of all reporting groups
Overall Number of Baseline Participants 12 8 8 8 36
Hide Baseline Analysis Population Description
Participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 8 participants 8 participants 8 participants 36 participants
49.5  (6.3) 55.0  (4.9) 54.5  (5.6) 51.4  (6.9) 52.3  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 8 participants 8 participants 8 participants 36 participants
Female
4
  33.3%
3
  37.5%
2
  25.0%
1
  12.5%
10
  27.8%
Male
8
  66.7%
5
  62.5%
6
  75.0%
7
  87.5%
26
  72.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 8 participants 8 participants 8 participants 36 participants
White
10
  83.3%
8
 100.0%
8
 100.0%
8
 100.0%
34
  94.4%
Black/African American
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
Multiple
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 8 participants 8 participants 8 participants 36 participants
12
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
36
 100.0%
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve (AUC)
Hide Description The area under the plasma concentration versus time curve from 0 hours to infinity (AUC [0-∞]) for LY2216684 is presented.
Time Frame Up to 72 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug.
Arm/Group Title Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Hide Arm/Group Description:
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
Overall Number of Participants Analyzed 12 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours times nanograms/milliliter
601
(503% to 717%)
742
(598% to 922%)
961
(774% to 1194%)
1020
(820% to 1265%)
2.Primary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Up to 72 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug.
Arm/Group Title Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Hide Arm/Group Description:
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
Overall Number of Participants Analyzed 12 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter
46.8
(27%)
39.6
(28%)
41.9
(33%)
34.7
(15%)
3.Primary Outcome
Title Pharmacokinetics: Time to Maximum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Up to 72 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug.
Arm/Group Title Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Hide Arm/Group Description:
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A)
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B)
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
Overall Number of Participants Analyzed 12 8 8 8
Median (Full Range)
Unit of Measure: hours
3.00
(1.00 to 5.00)
3.50
(2.00 to 6.00)
3.50
(1.00 to 5.00)
3.50
(2.00 to 5.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Hide Arm/Group Description LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C)
All-Cause Mortality
Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normal Hepatic Function Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/12 (50.00%)      3/8 (37.50%)      6/8 (75.00%)      5/8 (62.50%)    
Cardiac disorders         
Palpitations  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  2
Ear and labyrinth disorders         
Tinnitus  1  0/12 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 2/8 (25.00%)  2
Eye disorders         
Blepharitis  1  0/12 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Vision blurred  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Gastrointestinal disorders         
Abdominal discomfort  1  0/12 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Constipation  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  2
Dry mouth  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Nausea  1  2/12 (16.67%)  2 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Vomiting  1  1/12 (8.33%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
General disorders         
Fatigue  1  0/12 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Feeling abnormal  1  0/12 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  1/12 (8.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Urinary tract infection  1  0/12 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  1/12 (8.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders         
Dizziness  1  3/12 (25.00%)  3 0/8 (0.00%)  0 1/8 (12.50%)  1 2/8 (25.00%)  2
Encephalopathy  1  0/12 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Headache  1  0/12 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 2/8 (25.00%)  2
Somnolence  1  0/12 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1
Psychiatric disorders         
Hallucination  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Insomnia  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Renal and urinary disorders         
Micturition urgency  1  1/12 (8.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Pollakiuria  1  0/12 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Urinary hesitation  1  1/12 (8.33%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  1  1/12 (8.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  1/12 (8.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01241435     History of Changes
Other Study ID Numbers: 12602
H9P-EW-LNCM ( Other Identifier: Eli Lilly and Company )
First Submitted: November 12, 2010
First Posted: November 16, 2010
Results First Submitted: February 17, 2018
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018