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Trial record 12 of 27 for:    Edivoxetine OR LY2216684

A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01389752
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : October 19, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: LY2216684
Drug: Activated Charcoal
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2216684 Without Charcoal, Then With Charcoal LY2216684 With Charcoal, Then Without Charcoal
Hide Arm/Group Description Period 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days. Period 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Periods will be separated by a minimum of 7 days.
Period Title: Study Period 1
Started 11 11
Completed 11 9
Not Completed 0 2
Reason Not Completed
Sponsor decision             0             2
Period Title: Study Period 2
Started 11 9
Completed 10 9
Not Completed 1 0
Reason Not Completed
Sponsor decision             1             0
Arm/Group Title Overall
Hide Arm/Group Description During Study Period 1, participants received a single oral dose of 18 mg LY2216684 alone or in combination with 1 g/kg Activated Charcoal 1 hour after LY2216684 administration. After at least 7 days, participants who initially received 18 mg LY2216684 alone received another single oral dose of 18 mg LY2216684 in combination with 1 g/kg Activated Charcoal 1 hour after LY2216684 administration during Study Period 2; participants who initially received 18 mg LY2216684 in combination with 1 g/kg Activated Charcoal received another single oral dose of 18 mg LY2216684 alone during Study Period 2.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
35.2  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
13
  59.1%
Not Hispanic or Latino
8
  36.4%
Unknown or Not Reported
1
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  27.3%
White
15
  68.2%
More than one race
1
   4.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
 100.0%
1.Primary Outcome
Title Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
Hide Description The AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Time Frame Predose, up to 72 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, for whom AUC0-∞ data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684.
Arm/Group Title LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Hide Arm/Group Description:
Participants received a single oral dose of 18 mg (milligram) LY2216684 and a single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal 1 hour after administration of LY2216684.
Participants received a single oral dose of 18 mg LY2216684.
Overall Number of Participants Analyzed 17 19
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram*hour/milliliter (ng*h/mL)
509
(454 to 571)
786
(701 to 881)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 in Combination With Activated Charcoal, LY2216684 Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.65
Confidence Interval (2-Sided) 90%
0.61 to 0.68
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684
Hide Description The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Time Frame Predose, up to 72 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, for whom Cmax data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684.
Arm/Group Title LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Hide Arm/Group Description:
Participants received a single oral dose of 18 mg LY2216684 and a single oral dose of 1 g/kg of Activated Charcoal 1 hour after administration of LY2216684.
Participants received a single oral dose of 18 mg LY2216684.
Overall Number of Participants Analyzed 17 19
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram/milliliter (ng/mL)
54.06
(49.16 to 59.44)
59.84
(54.55 to 65.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 in Combination With Activated Charcoal, LY2216684 Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.90
Confidence Interval (2-Sided) 90%
0.83 to 0.98
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Hide Description The tmax for LY2216684 was assessed.
Time Frame Predose, up to 72 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, for whom tmax data were available, and who were not excluded due to vomiting within twice the median tmax of LY2216684.
Arm/Group Title LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Hide Arm/Group Description:
Participants received a single oral dose of 18 mg LY2216684 and a single oral dose of 1 g/kg of Activated Charcoal 1 hour after administration of LY2216684.
Participants received a single oral dose of 18 mg LY2216684.
Overall Number of Participants Analyzed 17 17
Median (Full Range)
Unit of Measure: hours
2.00
(0.92 to 3.00)
2.03
(2.00 to 5.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 in Combination With Activated Charcoal, LY2216684 Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 90%
-1.04 to -0.50
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Hide Arm/Group Description Participants received a single oral dose of 18 mg (milligram) LY2216684 and a single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal 1 hour after administration of LY2216684. Participants received a single oral dose of 18 mg LY2216684.
All-Cause Mortality
LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2216684 in Combination With Activated Charcoal LY2216684 Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/22 (40.91%)      7/20 (35.00%)    
Gastrointestinal disorders     
Nausea  1  2/22 (9.09%)  3 1/20 (5.00%)  1
Vomiting  1  5/22 (22.73%)  5 1/20 (5.00%)  1
General disorders     
Vessel puncture site pain  1  0/22 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  0/22 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
Dizziness  1  2/22 (9.09%)  2 0/20 (0.00%)  0
Headache  1  3/22 (13.64%)  3 0/20 (0.00%)  0
Psychiatric disorders     
Insomnia  1  0/22 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
Urinary hesitation  1  0/22 (0.00%)  0 1/20 (5.00%)  1
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/11 (9.09%)  1 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14
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: NCT01389752     History of Changes
Other Study ID Numbers: 12612
H9P-EW-LNCU ( Other Identifier: Eli Lilly and Company )
First Submitted: July 6, 2011
First Posted: July 8, 2011
Results First Submitted: February 17, 2018
Results First Posted: October 19, 2018
Last Update Posted: January 4, 2019