Clinical trial NCT02342314: A Study of LY3143753 and LY3185643 in Healthy Participants
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline to Study Completion (Up to 84 Days)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A
timeFrame: 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
measure: PK: Cmax of Part B
timeFrame: 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
measure: PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A
timeFrame: 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
measure: PK: AUC(0-∞) of Part B
timeFrame: 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
measure: PK: Time to Maximum Drug Concentration (Tmax) of Part A
timeFrame: 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
measure: PK: Tmax of Part B
timeFrame: 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
measure: Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A
timeFrame: 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
measure: PD Absolute Maximum Blood Glucose of Part B
timeFrame: 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
measure: PD: Maximum Glucose Increase (Gmax) of Part A
timeFrame: 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
measure: PD: Gmax of Part B
timeFrame: 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
measure: PD: Time to Maximum Blood Glucose (Gtmax) of Part A
timeFrame: 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
measure: PD: Gtmax of Part B
timeFrame: 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
measure: QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A
timeFrame: Baseline, 8 hours after drug administration
measure: QTcF Change From Baseline of Part B
timeFrame: Baseline, 8 hours after drug administration
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: