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A Study of Two Formulations of LY3074828 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: NCT03662100
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.


Condition or disease Intervention/treatment Phase
Healthy Biological: LY3074828 Drug: LY3074828 Device: Auto-injector (AI) Device: Prefilled syringe (PFS) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 2-mL Autoinjector in Healthy Subjects
Actual Study Start Date : September 6, 2018
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3074828 Reference 1
Solution formulation in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm
 Biological: LY3074828
Administered SC

Device: Prefilled syringe (PFS)
PFS to administer LY3074828
Experimental: LY3074828 Reference 2
Solution formulation in PFS administered as SC injection in thigh
 Biological: LY3074828
Administered SC

Device: Prefilled syringe (PFS)
PFS to administer LY3074828
Experimental: LY3074828 Reference 3
Solution formulation in PFS administered as SC injection in abdomen
 Biological: LY3074828
Administered SC

Device: Prefilled syringe (PFS)
PFS to administer LY3074828
Experimental: LY3074828 Test 1
Solution formulation administered SC via an auto-injector (AI) in arm
 Drug: LY3074828
Administered SC

Device: Auto-injector (AI)
AI to administer LY3074828
Experimental: LY3074828 Test 2
Solution formulation administered SC via an AI in thigh
 Drug: LY3074828
Administered SC

Device: Auto-injector (AI)
AI to administer LY3074828
Experimental: LY3074828 Test 3
Solution formulation administered SC via an AI in abdomen
 Drug: LY3074828
Administered SC

Device: Auto-injector (AI)
AI to administer LY3074828


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 [ Time Frame: Baseline through Day 85 ]
    Pharmacokinetics: Cmax of LY3074828

  2. Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) of LY3074828 [ Time Frame: Baseline through Day 85 ]
    Pharmacokinetics: AUC of LY3074828

  3. Visual Analogue Scale (VAS) Pain Assessment [ Time Frame: Day 1, 0 hour ]
    The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
  • Must not show evidence of active or latent tuberculosis (TB)
  • Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
  • Must not have been treated with steroids within 1 month of screening, or intend to during the study
  • Must not be immunocompromised
  • Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
  • Must not have significant allergies to humanised monoclonal antibodies
  • Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
  • Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Must not have had breast cancer within the past 10 years
Contacts and Locations
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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): NCT03662100


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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03662100    
Other Study ID Numbers: 16618
I6T-MC-AMAR ( Other Identifier: Eli Lilly and Company )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 1, 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Mirikizumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents