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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LY2189265 + Atorvastatin

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.


Participant Flow:   Overall Study
    LY2189265 + Atorvastatin
STARTED   27 
COMPLETED   27 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LY2189265 + Atorvastatin

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.


Baseline Measures
   LY2189265 + Atorvastatin 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.7  (15.1) 
Gender 
[Units: Participants]
 
Female   12 
Male   15 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   27 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   25 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United Kingdom   27 


  Outcome Measures

1.  Primary:   Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)   [ Time Frame: Pre-dose to 56 hours post-dose ]

2.  Primary:   Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)   [ Time Frame: Pre-dose to 56 hours post-dose ]

3.  Secondary:   Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)   [ Time Frame: Pre-dose to 56 hours post-dose ]

4.  Secondary:   Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)   [ Time Frame: Pre-dose to 56 hours post-dose ]

5.  Secondary:   Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)   [ Time Frame: Pre-dose to 56 hours post-dose ]

6.  Secondary:   Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)   [ Time Frame: Pre-dose to 56 hours post-dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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