Clinical trial NCT03325387: A Study of Multiple Doses of LY3305677 in Healthy Participants
Official title: A Multiple-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: 2017-10-30
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of this study are to determine:

* The safety of LY3305677 and any side effects that might be associated with it.
* How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin.
* The effect LY3305677 has on the body, particularly the effect on blood glucose levels.

This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study.

This study is for research purposes only and is not intended to treat any medical conditions.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
* Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan
* Have a body weight of more than 54 kilograms (kg)

Exclusion Criteria:

* Currently enrolled in a clinical study or have participated in a study within the past 3 months
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
* Have history of pancreatitis
* Have known or ongoing psychiatric disorders
* Have undergone bariatric surgery or have used any drugs for weight loss
* Have a history of alcoholism
* Currently smoke more than 10 cigarettes a 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 through 115 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677
timeFrame: Days 1 and 29: Predose through 168 hours post dose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677
timeFrame: Days 1 and 29: Predose through 168 hours post dose
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.
state: West Yorkshire
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: