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A Study of Ixekizumab 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: NCT03848416
Recruitment Status : Completed
First Posted : February 20, 2019
Results First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ixekizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Relative Bioavailability of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation in Healthy Subjects
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : June 7, 2019
Actual Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Ixekizumab (Reference)
Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.
Biological: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Ixekizumab (Test 1)
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
Biological: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Ixekizumab (Test 2)
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
Biological: Ixekizumab
Administered SC
Other Name: LY2439821




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab [ Time Frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose ]
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab

  2. PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab [ Time Frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose ]
    Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC[0-tlast]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.

  3. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. [ Time Frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose ]
    Area under the plasma concentration versus time curve from zero to infinity (AUC[0-∞]) of a single dose of Ixekizumab.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male participant or female participant who agree to not become pregnant
  • Are male participant or female participants with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study

Exclusion Criteria:

  • Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
  • Are allergic or hypersensitive to the study medicine
  • Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
  • Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
  • Show evidence of active or latent tuberculosis (TB)
  • Presence of significant neuropsychiatric disorder or a recent history of depression
  • Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant, if participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848416


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] May 9, 2019
Statistical Analysis Plan  [PDF] December 13, 2018

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03848416    
Other Study ID Numbers: 17140
I1F-MC-RHCT ( Other Identifier: Eli Lilly and Company )
First Posted: February 20, 2019    Key Record Dates
Results First Posted: June 24, 2020
Last Update Posted: June 24, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ixekizumab
Dermatologic Agents