A Study of LY2940680 in Healthy Participants

NCT ID: NCT01681186

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-12-31

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

LY2940680 (Part A)

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

Group Type: EXPERIMENTAL

LY2940680 Capsule(s) (Reference)

Intervention Type: DRUG

Administered orally as a capsule(s)

Placebo (Part A)

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

Group Type: PLACEBO_COMPARATOR

Placebo Capsule(s)

Intervention Type: DRUG

Administered orally as a capsule(s)

LY2940680 Capsule Fasted (Part B)

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

Group Type: EXPERIMENTAL

LY2940680 Capsule(s) (Reference)

Intervention Type: DRUG

Administered orally as a capsule(s)

LY2940680 Tablet Fasted (Part B)

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

Group Type: EXPERIMENTAL

LY2940680 Tablet (Test)

Intervention Type: DRUG

Administered orally as a tablet

LY2940680 Tablet Fed (Part B)

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 Type: EXPERIMENTAL

LY2940680 Tablet (Test)

Intervention Type: DRUG

Administered orally as a tablet

LY2940680 Tablet Fasted + PPI (Part B)

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

Group Type: EXPERIMENTAL

LY2940680 Tablet (Test)

Intervention Type: DRUG

Administered orally as a tablet

Lansoprazole

Intervention Type: DRUG

Administered orally as a capsule

Interventions

LY2940680 Capsule(s) (Reference)

Administered orally as a capsule(s)

Intervention Type: DRUG

LY2940680 Tablet (Test)

Administered orally as a tablet

Intervention Type: DRUG

Lansoprazole

Administered orally as a capsule

Intervention Type: DRUG

Placebo Capsule(s)

Administered orally as a capsule(s)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and physical examination
• 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
• Prepared to eat an entire high fat breakfast

Exclusion Criteria

• Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product
• Have known allergies to LY2940680, related compounds or any components of the formulation, or known allergies to lansoprazole (Part B only)
• Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product. Participants in Part A are not allowed to participate in Part B
• Have an abnormality in the 12-lead electrocardiogram (ECG)
• 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)
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• 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
• Have used or intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study. Exception: participants may continue hormone replacement therapy (HRT; estrogen)
• Use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or Starfruit within 7 days prior to dosing or during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

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, Texas, United States

Countries

United States

Other Identifiers

I4J-MC-HHBG

Identifier Type: OTHER

Identifier Source: secondary_id

14893

Identifier Type: -

Identifier Source: org_study_id