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A Study of LY2623091 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: NCT02300259
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 24, 2014
Last Update Posted Date April 17, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2623091 and Cytochrome (CYP) P450 Substrates [ Time Frame: Predose up to 20 days after drug administration in each period ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2623091 and Cytochrome (CYP) P450 Substrates [ Time Frame: Predose up to 20 days after drug administration in each period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02300259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY2623091 in Healthy Participants
Official Title  ICMJE A Study to Determine the Effect of CYP3A Inhibition on the Pharmacokinetics of LY2623091 and the Effect of LY2623091 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects
Brief Summary

The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.

The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.

The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.

There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: LY2623091
    Administered orally
  • Drug: Itraconazole
    Administered orally
  • Drug: Simvastatin
    Administered orally
  • Drug: Tadalafil
    Administered orally
  • Drug: Diltiazem
    Administered orally
Study Arms  ICMJE
  • Experimental: LY2623091 (Group 1)
    LY2623091 administered orally once on Day 1 of Period 1.
    Intervention: Drug: LY2623091
  • Experimental: Itraconazole + LY2623091 (Group 1)
    200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2.
    Interventions:
    • Drug: LY2623091
    • Drug: Itraconazole
  • Experimental: Simvastatin (Group 2)
    20 mg simvastatin administered orally once daily on Day 1.
    Intervention: Drug: Simvastatin
  • Experimental: LY2623091 + Simvastatin (Group 2)
    LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12.
    Interventions:
    • Drug: LY2623091
    • Drug: Simvastatin
  • Experimental: Tadalafil (Group 3)
    5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.
    Intervention: Drug: Tadalafil
  • Experimental: Tadalafil + LY2623091 (Group 3)
    LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2.
    Interventions:
    • Drug: LY2623091
    • Drug: Tadalafil
  • Experimental: LY2623091 (Group 4)
    LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.
    Intervention: Drug: LY2623091
  • Experimental: Diltiazem + LY2623091 (Group 4)
    240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2.
    Interventions:
    • Drug: LY2623091
    • Drug: Diltiazem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).
  • Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2) inclusive, at screening
  • Female participants must be of non-childbearing potential

Exclusion Criteria:

  • In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300259
Other Study ID Numbers  ICMJE 15523
I7T-MC-RMAG ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559 Mon ‐ Fri 9 AM ‐ 5 PM Eastern time (UTC/GMT ‐ 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP