Completed

A Single Ascending Dose and Relative Bioavailability Study of LY2940680 in Healthy Subjects

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LY2940680 Capsule(s) (Reference)

+ Placebo Capsule(s)

+ LY2940680 Capsule(s) (Reference)

Drug
Who is being recruted

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-ControlledPhase 1
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: October 21, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the safety and side effects of LY2940680 in healthy participants. Part A will involve two groups of participants, each taking up to two single doses of LY2940680 at different dose levels. There is a minimum 14 day washout period between each of the participant's doses. The purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets into the bloodstream and how long the body takes to get rid of it. In addition, the effect of food and a proton pump inhibitor (PPI) on LY2940680 will be studied. Part B will involve one group of participants who will take four single doses of 100 milligrams (mg) LY2940680. There is a minimum 7 day washout period between doses. Participants may only enroll in one part. Screening is required within 28 days prior to the start of the study.

NCT01681186
Principal SponsorEli Lilly and Company
Last updated: October 21, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Body mass index of 18.5 to 32.0 kilograms per meter square (kg/m^2)
Have clinical laboratory test results within normal reference range
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and physical examination
Show More Criteria
11 exclusion criteria prevent from participating
Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data (cholecystectomy or appendectomy are allowed if surgery at least 6 months prior to screening)
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have known allergies to LY2940680, related compounds or any components of the formulation, or known allergies to lansoprazole (Part B only)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

16.667% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods

Group II

Placebo
Placebo given once orally in up to 1 of 2 study periods

Group III

Experimental
100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods

Group IV

Experimental
100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods

Group 5

Experimental
100 mg LY2940680 given once orally as a tablet (test formulation) in fed state following a standardized, high-fat breakfast in 1 of 4 study periods

Group 6

Experimental
30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 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.

Dallas, United StatesOpen 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. in Google Maps
CompletedOne Study Center