Clinical trial NCT02972645: A Study of LY3305677 in Healthy Participants
Official title: A First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.

This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.

This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).

Participation in this study is expected to last up to 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy as determined by medical history and physical examination
* Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
* Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
* First generation Japanese participants or non-Japanese participants
* Have a body weight of more than 50 kilograms (kg)

Exclusion Criteria:

* Have participated within the last 3 months in a clinical trial involving an investigational product
* Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
* Have undergone any form of bariatric surgery
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
* Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
* Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
* Have used or intend to use medications that promote weight loss
* Have donated blood of more than 500 milliliter (mL) within the last month
* Currently smoke more than 10 cigarettes per day

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 (approximately 16 weeks)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677
timeFrame: Day 1 Pre-dose through Day 85
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677
timeFrame: Day 1 Pre-dose through Day 85
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, 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: