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Trial record 3 of 39 for:    LY2189265

LY2189265 and Atorvastatin Interaction Study

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ClinicalTrials.gov Identifier: NCT01250834
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : October 8, 2014
Last Update Posted : October 8, 2014
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 Healthy Volunteers
Interventions Drug: Atorvastatin
Biological: LY2189265
Enrollment 27

Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2189265 + Atorvastatin
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Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.

Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.

Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title LY2189265 + Atorvastatin
Hide Arm/Group Description

Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.

Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
42.7  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
12
  44.4%
Male
15
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
27
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.7%
White
25
  92.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 27 participants
27
1.Primary Outcome
Title Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Pre-dose to 56 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Arm/Group Title 40 mg Atorvastatin Alone 1.5 mg LY2189265 + 40 mg Atorvastatin
Hide Arm/Group Description:
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Overall Number of Participants Analyzed 27 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
19.5
(60%)
5.78
(86%)
2.Primary Outcome
Title Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)
Hide Description This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.
Time Frame Pre-dose to 56 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Arm/Group Title 40 mg Atorvastatin Alone 1.5 mg LY2189265 + 40 mg Atorvastatin
Hide Arm/Group Description:
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Overall Number of Participants Analyzed 27 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
82.8
(33%)
65.9
(35%)
3.Secondary Outcome
Title Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Pre-dose to 56 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Arm/Group Title 40 mg Atorvastatin Alone 1.5 mg LY2189265 + 40 mg Atorvastatin
Hide Arm/Group Description:
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Overall Number of Participants Analyzed 27 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
0.473
(81%)
0.360
(69%)
4.Secondary Outcome
Title Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)
Hide Description This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.
Time Frame Pre-dose to 56 hours post-dose
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Pre-dose to 56 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Arm/Group Title 40 mg Atorvastatin Alone 1.5 mg LY2189265 + 40 mg Atorvastatin
Hide Arm/Group Description:
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Overall Number of Participants Analyzed 27 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
14.4
(46%)
5.66
(60%)
6.Secondary Outcome
Title Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)
Hide Description This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.
Time Frame Pre-dose to 56 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.
Arm/Group Title 40 mg Atorvastatin Alone 1.5 mg LY2189265 + 40 mg Atorvastatin
Hide Arm/Group Description:
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Overall Number of Participants Analyzed 27 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
102
(30%)
95.9
(28%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 40 mg Atorvastatin Alone 1.5 mg LY2189265 1.5 mg LY2189265 + 40 mg Atorvastatin
Hide Arm/Group Description Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2. Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3. Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
All-Cause Mortality
40 mg Atorvastatin Alone 1.5 mg LY2189265 1.5 mg LY2189265 + 40 mg Atorvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
40 mg Atorvastatin Alone 1.5 mg LY2189265 1.5 mg LY2189265 + 40 mg Atorvastatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
40 mg Atorvastatin Alone 1.5 mg LY2189265 1.5 mg LY2189265 + 40 mg Atorvastatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/27 (29.63%)      23/27 (85.19%)      16/27 (59.26%)    
Eye disorders       
Eyelid oedema  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Gastrointestinal disorders       
Abdominal discomfort  1  0/27 (0.00%)  0 2/27 (7.41%)  2 0/27 (0.00%)  0
Abdominal distension  1  0/27 (0.00%)  0 9/27 (33.33%)  10 1/27 (3.70%)  2
Abdominal pain  1  0/27 (0.00%)  0 0/27 (0.00%)  0 3/27 (11.11%)  3
Abdominal pain upper  1  0/27 (0.00%)  0 1/27 (3.70%)  1 1/27 (3.70%)  1
Abdominal tenderness  1  0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Breath odour  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Diarrhoea  1  1/27 (3.70%)  1 0/27 (0.00%)  0 2/27 (7.41%)  2
Dry mouth  1  1/27 (3.70%)  2 0/27 (0.00%)  0 0/27 (0.00%)  0
Dyspepsia  1  0/27 (0.00%)  0 1/27 (3.70%)  1 3/27 (11.11%)  5
Flatulence  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Nausea  1  0/27 (0.00%)  0 9/27 (33.33%)  9 3/27 (11.11%)  4
Toothache  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Vomiting  1  0/27 (0.00%)  0 4/27 (14.81%)  5 4/27 (14.81%)  4
General disorders       
Fatigue  1  0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Feeling hot  1  1/27 (3.70%)  1 2/27 (7.41%)  3 0/27 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  0/27 (0.00%)  0 0/27 (0.00%)  0 2/27 (7.41%)  2
Tonsillitis  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  0/27 (0.00%)  0 12/27 (44.44%)  12 3/27 (11.11%)  3
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Back pain  1  0/27 (0.00%)  0 1/27 (3.70%)  1 1/27 (3.70%)  1
Musculoskeletal stiffness  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Pain in extremity  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Plantar fasciitis  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/27 (0.00%)  0 2/27 (7.41%)  2 0/27 (0.00%)  0
Headache  1  0/27 (0.00%)  0 3/27 (11.11%)  3 1/27 (3.70%)  1
Lethargy  1  0/27 (0.00%)  0 3/27 (11.11%)  3 0/27 (0.00%)  0
Paraesthesia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Presyncope  1  0/27 (0.00%)  0 1/27 (3.70%)  1 1/27 (3.70%)  1
Somnolence  1  0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Psychiatric disorders       
Insomnia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Reproductive system and breast disorders       
Menstruation irregular  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders       
Dry throat  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Epistaxis  1  0/27 (0.00%)  0 1/27 (3.70%)  1 1/27 (3.70%)  1
Oropharyngeal pain  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Rhinorrhoea  1  2/27 (7.41%)  2 1/27 (3.70%)  1 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/27 (0.00%)  0 1/27 (3.70%)  2 0/27 (0.00%)  0
Needle track marks  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Rash  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01250834     History of Changes
Other Study ID Numbers: 11551
H9X-MC-GBCP ( Other Identifier: Eli Lilly and Company )
2010-021657-39 ( EudraCT Number )
First Submitted: November 29, 2010
First Posted: December 1, 2010
Results First Submitted: October 3, 2014
Results First Posted: October 8, 2014
Last Update Posted: October 8, 2014