A Study of Multiple Doses of LY3305677 in Healthy Participants

Healthy Clinical Trial

Official title:

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325387
• Other study ID #: 16619
• Secondary ID: I8P-MC-OXAB
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2017
• Est. completion date: August 3, 2018

Study information

• Verified date: August 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3305677
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United Kingdom	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.	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 115 days
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677	PK: Cmax of LY3305677	Days 1 and 29: Predose through 168 hours post dose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677	PK: AUC of LY3305677	Days 1 and 29: Predose through 168 hours post dose