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A Study of Different Injectable Formulations of LY3375880 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03913260
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3375880 Drug: Buffer Matrix (No LY3375880) Device: Autoinjector (AI) Device: Manual Syringe Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Part A is a crossover design. Part B is a parallel design.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 25, 2019
Estimated Study Completion Date : September 25, 2019

Arm Intervention/treatment
Experimental: Part A: LY3375880 Formulation A
LY3375880 Formulation A administered subcutaneously (SC).
Drug: LY3375880
Administered SC

Device: Autoinjector (AI)
AI used to administer LY3375880 or Buffer Matrix

Experimental: Part A: LY3375880 Formulation B
LY3375880 Formulation B administered subcutaneously SC.
Drug: LY3375880
Administered SC

Device: Autoinjector (AI)
AI used to administer LY3375880 or Buffer Matrix

Experimental: Part A: LY3375880 Formulation C
LY3375880 Formulation C administered SC.
Drug: LY3375880
Administered SC

Device: Autoinjector (AI)
AI used to administer LY3375880 or Buffer Matrix

Placebo Comparator: Part A: Positive Control
Positive Control (buffer matrix, only) administered SC.
Drug: Buffer Matrix (No LY3375880)
Administered SC

Device: Autoinjector (AI)
AI used to administer LY3375880 or Buffer Matrix

Experimental: Part B: LY3375880 Test 1
LY3375880 Test 1 Formulation administered SC.
Drug: LY3375880
Administered SC

Device: Manual Syringe
Manual syringe used to inject LY3375880

Experimental: Part B: LY3375880 Test 2
LY3375880 Test 2 Formulation administered SC.
Drug: LY3375880
Administered SC

Device: Manual Syringe
Manual syringe used to inject LY3375880

Experimental: Part B: LY3375880 Test 3
LY3375880 Test 3 Formulation administered SC.
Drug: LY3375880
Administered SC

Device: Manual Syringe
Manual syringe used to inject LY3375880




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) Pain Score [ Time Frame: Part A: Within 1-minute post injection ]
    The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).

  2. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880 [ Time Frame: Part B: Predose through Day 85 ]
    PK: Cmax of LY3375880

  3. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880 [ Time Frame: Part B: Predose through Day 85 ]
    PK: AUC of LY3375880



Information from the National Library of Medicine

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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:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
  • Females who are not of child-bearing potential
  • Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

  • Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
  • Have participated or are currently enrolled in clinical trials with LY3375880
  • Have infections or evidence of infections
  • Are pregnant, lactating or breast feeding

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): NCT03913260


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Gatekeeper_CTR@Lilly.com

Locations
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United States, Florida
Covance Clinical Research Inc Not yet recruiting
Daytona Beach, Florida, United States, 32117
Contact    386-257-5717      
Principal Investigator: Hugh A Coleman         
United States, Texas
Covance Not yet recruiting
Dallas, Texas, United States, 75247
Contact    469-513-6727      
Principal Investigator: Jennifer T Zon         
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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03913260     History of Changes
Other Study ID Numbers: 17212
I9N-MC-FCAC ( Other Identifier: Eli Lilly and Company )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 15, 2019
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
Product Manufactured in and Exported from the U.S.: Yes