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Completed

NCT Number: NCT02342314

A Study of LY3143753 and LY3185643 in Healthy Participants

The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overtly healthy males or females
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

  • Are investigator site personnel directly affiliated with this study and their immediate families
  • Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
  • Have participated, within the last 3 months, in a clinical trial
  • Have known or ongoing psychiatric disorders
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • History of/current phaeochromocytoma
  • History of/current insulinoma

Treatment and study plan

LY3143753 (Part A)

Drug

Administered via SC injection

LY3185643 (Part B)

Drug

Administered via SC injection

Placebo (Part A and Part B)

Drug

Administered via SC injection

rGlucagon (Part B)

Drug

Administered via SC injection

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline to Study Completion (Up to 84 Days)

    A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours

  2. PK: Cmax of Part B

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours

  3. PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours

  4. PK: AUC(0-∞) of Part B

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours

  5. PK: Time to Maximum Drug Concentration (Tmax) of Part A

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours

  6. PK: Tmax of Part B

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours

  7. Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours

  8. PD Absolute Maximum Blood Glucose of Part B

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours

  9. PD: Maximum Glucose Increase (Gmax) of Part A

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours

  10. PD: Gmax of Part B

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours

  11. PD: Time to Maximum Blood Glucose (Gtmax) of Part A

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours

  12. PD: Gtmax of Part B

    Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours

  13. QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A

    Time frame: Baseline, 8 hours after drug administration

  14. QTcF Change From Baseline of Part B

    Time frame: Baseline, 8 hours after drug administration

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 19, 2015
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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