A Study of LY2940680 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: LY2940680 Capsule(s) (Reference); Drug: Placebo Capsule(s); Drug: LY2940680 Tablet (Test); Drug: Lansoprazole

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: LY2940680 Capsule(s) (Reference); Administered orally as a capsule(s)
Placebo Comparator: Placebo (Part A); Placebo given once orally in up to 1 of 2 study periods	Drug: Placebo Capsule(s); Administered orally as a capsule(s)
Experimental: 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	Drug: LY2940680 Capsule(s) (Reference); Administered orally as a capsule(s)
Experimental: 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	Drug: LY2940680 Tablet (Test); Administered orally as a tablet
Experimental: 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	Drug: LY2940680 Tablet (Test); Administered orally as a tablet
Experimental: 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	Drug: LY2940680 Tablet (Test); Administered orally as a tablet; Drug: Lansoprazole; Administered orally as a capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs	Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.	Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)
Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation	The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)	The Cmax of LY2940680 during Part A of the study was reported.	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)	Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)	Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]	Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)]	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]	Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)]	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]	Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]	Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 4, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 14893; I4J-MC-HHBG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO