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A Study of LY2484595 on Pharmacokinetics in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01448824
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy Participants
Interventions Drug: LY2484595
Drug: Placebo
Drug: Ketoconazole
Enrollment 82
Recruitment Details  
Pre-assignment Details This was a 2-part study, multiple ascending dose (MAD) and drug drug interaction (DDI). Participants were randomized to (Part 1) to 4 cohorts (Cohorts A through D) and randomized to receive either LY2484595 (5 ascending dose levels) or placebo. Cohort A consisted of 2 periods separated by a washout period of 14 days. DDI had 2 periods.
Arm/Group Title Part 1 Cohort A Sequence 1 Part 1 Cohort A Sequence 2 Part 1 Cohort A Sequence 3 Part 1 (Cohorts B Through D): Placebo Part 1 Cohort B Part 1 Cohort C Part 1 Cohort D Part 2 Cohort E
Hide Arm/Group Description

Period 1:

LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.

Washout period lasting ≥14 days.

Period 2:

LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2.

Period 1:

Placebo: dose-matched tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.

Washout period lasting ≥ 14 days

Period 2:

LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2.

Period 1:

LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1

Washout period lasting ≥14 days

Period 2:

Placebo: tablets, oral administration, QD on Days 1 through 14 of Period 2

Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14. LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14. LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14. LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1.

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2.

Period Title: Part 1 Period 1: Multiple Ascending Dose
Started 12 4 4 10 16 12 12 0
Received at Least 1 Dose of Study Drug 12 4 4 10 16 12 12 0
Completed 12 4 4 9 14 10 11 0
Not Completed 0 0 0 1 2 2 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0
Withdrawal by Subject             0             0             0             1             2             1             0             0
Lost to Follow-up             0             0             0             0             0             1             0             0
Period Title: Part 1: Washout Period
Started 12 4 4 0 [1] 0 [2] 0 [3] 0 [4] 0
Completed 11 4 4 0 0 0 0 0
Not Completed 1 0 0 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             1             0             0             0             0             0             0             0
[1]
Participants in Part 1 Cohorts B through D participated in Period 1 only.
[2]
Participants in Part 1 Cohort B participated in Period 1 only.
[3]
Participants in Part 1 Cohort C participated in Period 1 only.
[4]
Participants in Part 1 Cohort D participated in Period 1 only.
Period Title: Part 1 Period 2: Multiple Ascending Dose
Started 11 4 4 0 [1] 0 [2] 0 [3] 0 [4] 0
Received at Least 1 Dose 11 4 4 0 0 0 0 0
Completed 11 4 4 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0
[1]
Participants in Part 1 Cohorts B through D participated in Period 1 only.
[2]
Participants in Part 1 Cohort B participated in Period 1 only.
[3]
Participants in Part 1 Cohort C participated in Period 1 only.
[4]
Participants in Part 1 Cohort D participated in Period 1 only.
Period Title: Part 2 Period 1: Drug-drug Interaction
Started 0 0 0 0 0 0 0 12
Received at Least 1 Dose of Study Drug 0 0 0 0 0 0 0 12
Completed 0 0 0 0 0 0 0 11
Not Completed 0 0 0 0 0 0 0 1
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1
Period Title: Part 2: Washout Period
Started 0 0 0 0 0 0 0 11
Completed 0 0 0 0 0 0 0 11
Not Completed 0 0 0 0 0 0 0 0
Period Title: Part 2 Period 2: Drug-drug Interaction
Started 0 0 0 0 0 0 0 11
Received at Least 1 Dose of Study Drug 0 0 0 0 0 0 0 11
Completed Dosing on Day 5 0 0 0 0 0 0 0 10
Completed 0 0 0 0 0 0 0 8
Not Completed 0 0 0 0 0 0 0 3
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             0             0             0             1
Arm/Group Title Part 1 (Cohort A) Sequence 1 Part 1 (Cohort A) Sequence 2 Part 1 (Cohort A) Sequence 3 Part 1 (Cohort B Through D) Placebo Part 1 (Cohort B) Part 1 (Cohort C) Part 1 (Cohort D) Part 2 (Cohort E) Total
Hide Arm/Group Description Participants received 100 milligrams (mg) LY2484595 (tablets, oral administration) QD on Days 1 through 14. Then, received 1800 mg LY2484595 QD on Days 1 through 14 period 2. Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 and 1800 mg LY2484595 on Days 1 through 14 of Period 2). Participants received 100 mg LY2484595 (tablets, oral administration) once daily (QD) on Days 1 through 14. Then, received placebo QD on Days 1 through 14 period 2. Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14. Participants received 300 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14. Participants received 600 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14. Participants received 1200 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14. Participants received 100 mg LY2484595 (tablet, oral administration) as a single dose on Day 1 of Period 1. After a washout period lasting ≥14 days, participants received 400 mg ketoconazole (tablet, oral administration, QD) on Days 1 through 4 of Period 2, 400 mg ketoconazole (tablet, oral administration) and 100 mg LY2484595 (tablet, oral administration) on Day 5 of Period 2, and 400 mg ketoconazole (tablet, oral administration, QD) on Days 6 through 14 of Period 2. Total of all reporting groups
Overall Number of Baseline Participants 12 4 4 10 16 12 12 12 82
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 4 participants 4 participants 10 participants 16 participants 12 participants 12 participants 12 participants 82 participants
38.4  (11.6) 31.3  (3.9) 41.8  (7.4) 39.4  (13.7) 41.1  (14.3) 39.1  (10.7) 45.8  (11.0) 36.6  (7.9) 39.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 4 participants 10 participants 16 participants 12 participants 12 participants 12 participants 82 participants
Female 3 1 0 3 5 2 2 3 19
Male 9 3 4 7 11 10 10 9 63
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 4 participants 10 participants 16 participants 12 participants 12 participants 12 participants 82 participants
Hispanic or Latino 7 1 3 4 6 8 5 7 41
Not Hispanic or Latino 5 3 1 6 10 4 7 5 41
Unknown or Not Reported 0 0 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 4 participants 10 participants 16 participants 12 participants 12 participants 12 participants 82 participants
American Indian or Alaska Native 0 0 0 0 0 0 0 2 2
Asian 0 0 0 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0
Black or African American 3 1 1 3 5 2 1 5 21
White 9 2 3 7 9 10 8 5 53
More than one race 0 1 0 0 2 0 3 0 6
Unknown or Not Reported 0 0 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 4 participants 4 participants 10 participants 16 participants 12 participants 12 participants 12 participants 82 participants
12 4 4 10 16 12 12 12 82
1.Primary Outcome
Title Part 1: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Hide Description The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time Frame Part 1: Baseline through ≥14 days after last dose of study drug (≥Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Part 1 (Cohorts A Through D): Placebo Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Hide Arm/Group Description:
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Overall Number of Participants Analyzed 18 16 16 12 12 15
Measure Type: Number
Unit of Measure: Participants
AEs 7 2 4 2 6 11
Serious AEs 0 0 0 0 0 0
2.Primary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
Hide Description The geometric least squares (LS) means for the maximum observed plasma concentration (Cmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Time Frame Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
Arm/Group Title Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Hide Arm/Group Description:

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Overall Number of Participants Analyzed 12 10
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Nanograms per milliliter (ng/mL)
331.83
(236.06 to 466.45)
643.99
(448.78 to 924.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2, Period 1: 100 mg LY2484595, Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of ~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.94
Confidence Interval (2-Sided) 90%
1.39 to 2.72
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
Hide Description The median times to maximum observed plasma concentration (Tmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported.
Time Frame Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
Arm/Group Title Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Hide Arm/Group Description:

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: Hours (h)
3.00
(2.00 to 4.00)
3.00
(2.00 to 3.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2, Period 1: 100 mg LY2484595, Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.50 to 0.50
Estimation Comments [Not Specified]
4.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
Hide Description The geometric least squares (LS) means of area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Time Frame Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).
Arm/Group Title Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Hide Arm/Group Description:

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Overall Number of Participants Analyzed 12 9
Geometric Mean (90% Confidence Interval)
Unit of Measure: Nanograms * hours per milliliter
5265
(4106 to 6751)
12471
(9422 to 16508)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2, Period 1: 100 mg LY2484595, Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of ~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.
Method of Estimation Estimation Parameter Ratio of Geometric LS means
Estimated Value 2.37
Confidence Interval (2-Sided) 90%
1.77 to 3.18
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pharmacodynamics: Change From Baseline to Day 21 in Cholesteryl Ester Transfer Protein (CETP) Activity
Hide Description [Not Specified]
Time Frame Day 1 (Baseline) and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2484595 or placebo and had evaluable pharmacodynamic (CETP) data.
Arm/Group Title Part 1 (Cohorts A Through D): Placebo Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Hide Arm/Group Description:
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Overall Number of Participants Analyzed 18 16 15 11 11 15
Mean (Standard Deviation)
Unit of Measure: Picomoles per milliliters per minute
1.3  (6.9) -0.4  (3.1) -0.4  (6.3) -9.1  (8.8) -9.5  (5.0) -12.9  (7.5)
6.Secondary Outcome
Title Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
Hide Description [Not Specified]
Time Frame Day 1 (Baseline) and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2484595 or placebo during Period 1 and had evaluable pharmacodynamic (HDL-C, LDL-C, TG) data.
Arm/Group Title Part 1, Period 1 (Cohorts A Through D): Placebo Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595
Hide Arm/Group Description:
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts)
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
Overall Number of Participants Analyzed 14 16 15 11 11
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
HDL-C -0.08  (0.17) 0.35  (0.22) 0.49  (0.31) 0.77  (0.49) 0.80  (0.22)
LDL-C -0.42  (0.74) -0.16  (0.31) -0.48  (0.55) -1.15  (0.93) -1.01  (0.57)
TG 0.56  (0.87) 0.55  (0.81) 0.44  (0.61) 0.26  (0.38) 0.52  (0.57)
7.Secondary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
Time Frame Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
Arm/Group Title Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Hide Arm/Group Description:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Overall Number of Participants Analyzed 16 16 12 12 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter (ng/mL)
Day 1 Number Analyzed 16 participants 16 participants 12 participants 12 participants 15 participants
628
(79%)
1990
(60%)
2720
(59%)
4450
(53%)
3580
(73%)
Day 14 Number Analyzed 16 participants 15 participants 12 participants 11 participants 15 participants
978
(41%)
1970
(37%)
4180
(42%)
5410
(48%)
5750
(35%)
8.Secondary Outcome
Title Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
Hide Description The times of maximum observed plasma concentrations (tmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Time Frame Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug and had evaluable LY2484595 concentration data.
Arm/Group Title Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Hide Arm/Group Description:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Overall Number of Participants Analyzed 16 16 12 12 15
Median (Full Range)
Unit of Measure: Hours (h)
Day 1 Number Analyzed 16 participants 16 participants 12 participants 12 participants 15 participants
3.00
(2.00 to 8.00)
3.00
(1.00 to 8.00)
3.00
(2.00 to 4.00)
2.00
(1.00 to 8.00)
2.00
(1.00 to 4.00)
Day 14 Number Analyzed 16 participants 15 participants 12 participants 11 participants 15 participants
4.00
(2.00 to 6.00)
2.00
(2.00 to 4.00)
2.50
(1.00 to 4.00)
2.00
(1.00 to 6.00)
3.00
(1.00 to 6.00)
9.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
Hide Description Exposure to LY2484595 in terms of the area under the concentration-time curves (AUC) after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Time Frame Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).
Arm/Group Title Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Hide Arm/Group Description:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Overall Number of Participants Analyzed 16 16 12 12 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms * hour per milliliter
Day 1 Number Analyzed 16 participants 16 participants 12 participants 12 participants 15 participants
4780
(57%)
14500
(47%)
21300
(55%)
36300
(46%)
31300
(63%)
Day 14 Number Analyzed 16 participants 15 participants 12 participants 11 participants 15 participants
8110
(30%)
17900
(27%)
36200
(38%)
46900
(43%)
56600
(30%)
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Hide Arm/Group Description Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only) LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

Period 1:

LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1

Washout period lasting ≥ 14 days

Period 2:

Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2

LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2

All-Cause Mortality
Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/16 (0.00%)      0/15 (0.00%)      0/16 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/11 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/18 (38.89%)      2/16 (12.50%)      11/15 (73.33%)      4/16 (25.00%)      2/12 (16.67%)      6/12 (50.00%)      4/12 (33.33%)      5/11 (45.45%)      2/10 (20.00%)    
Eye disorders                   
Conjunctivitis  1  1/18 (5.56%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Eye irritation  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Eye pruritus  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Lacrimation increased  1  1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders                   
Abdominal distension  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  2 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain  1  1/18 (5.56%)  1 0/16 (0.00%)  0 6/15 (40.00%)  7 1/16 (6.25%)  1 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain upper  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Constipation  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Diarrhoea  1  0/18 (0.00%)  0 0/16 (0.00%)  0 10/15 (66.67%)  13 0/16 (0.00%)  0 0/12 (0.00%)  0 2/12 (16.67%)  3 0/12 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Dyspepsia  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Flatulence  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Gastrooesophageal reflux disease  1  0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Lip swelling  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Nausea  1  1/18 (5.56%)  1 0/16 (0.00%)  0 6/15 (40.00%)  9 1/16 (6.25%)  1 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 3/11 (27.27%)  3 0/10 (0.00%)  0
Oedema mouth  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Oral mucosal erythema  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Paraesthesia oral  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Vomiting  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
General disorders                   
Chills  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Fatigue  1  0/18 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Feeling abnormal  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Feeling hot  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Feeling jittery  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Irritability  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Pain  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 2/12 (16.67%)  2 0/11 (0.00%)  0 0/10 (0.00%)  0
Vessel puncture site pain  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations                   
Pharyngitis  1  1/18 (5.56%)  1 0/16 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Rhinitis  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Injury, poisoning and procedural complications                   
Excoriation  1  1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Laceration  1  1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Myalgia  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders                   
Dizziness  1  1/18 (5.56%)  1 0/16 (0.00%)  0 4/15 (26.67%)  4 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Headache  1  0/18 (0.00%)  0 0/16 (0.00%)  0 6/15 (40.00%)  16 1/16 (6.25%)  1 0/12 (0.00%)  0 3/12 (25.00%)  4 0/12 (0.00%)  0 4/11 (36.36%)  5 0/10 (0.00%)  0
Muscle contractions involuntary  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  2 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Somnolence  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Psychiatric disorders                   
Agitation  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Cough  1  1/18 (5.56%)  1 0/16 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Epistaxis  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Nasal congestion  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Oropharyngeal pain  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Rhinorrhoea  1  1/18 (5.56%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Sinus congestion  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Sneezing  1  0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Acne  1  0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Dry skin  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
Erythema  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Hyperhidrosis  1  1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Pruritus  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  2 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Pruritus generalised  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0
Rash  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
Rash generalised  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Urticaria  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders                   
Capillary fragility  1  0/18 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Flushing  1  0/18 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01448824    
Other Study ID Numbers: 14460
I1V-MC-EIAL ( Other Identifier: Eli Lilly and Company )
First Submitted: October 6, 2011
First Posted: October 7, 2011
Results First Submitted: February 18, 2018
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019