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A Study of Two Formulations 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: NCT04259346
Recruitment Status : Completed
First Posted : February 6, 2020
Results First Posted : April 8, 2022
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects
Actual Study Start Date : February 5, 2020
Actual Primary Completion Date : February 19, 2021
Actual Study Completion Date : February 19, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Ixekizumab (Reference)
Approved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI).
Drug: Ixekizumab
Administered SC.
Other Name: LY2439821

Experimental: Ixekizumab (Test)
Test formulation of 80 mg ixekizumab administered as a SC injection via AI.
Drug: 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 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose ]
    PK: Cmax of ixekizumab was evaluated

  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 8, Day 11, Day 15, Day 22, Day 29, 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 8, Day 11, Day 15, Day 22, Day 29, 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:

  • Are healthy male 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

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): NCT04259346


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Miami Research Associates
Miami, Florida, United States, 33143
United States, Texas
Covance Dallas
Dallas, Texas, United States, 75247
United States, Wisconsin
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704
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] September 29, 2020
Statistical Analysis Plan  [PDF] December 18, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04259346    
Other Study ID Numbers: 17151
I1F-MC-RHCU ( Other Identifier: Eli Lilly and Company )
First Posted: February 6, 2020    Key Record Dates
Results First Posted: April 8, 2022
Last Update Posted: April 8, 2022
Last Verified: February 1, 2022
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