A Study of LY2940680 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: LY2940680 Capsule(s) (Reference)
Drug: LY2940680 Tablet (Test)
Drug: Placebo Capsule(s)
Drug: Lansoprazole

Registration Number: NCT01681186

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product.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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY2940680 (Part A)	LY2940680 Capsule(s) (Reference)	Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods
LY2940680 Tablet Fasted + PPI (Part B)	LY2940680 Tablet (Test)	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
LY2940680 Capsule Fasted (Part B)	LY2940680 Capsule(s) (Reference)	100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods
LY2940680 Tablet Fed (Part B)	LY2940680 Tablet (Test)	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
Placebo (Part A)	Placebo Capsule(s)	Placebo given once orally in up to 1 of 2 study periods
LY2940680 Tablet Fasted (Part B)	LY2940680 Tablet (Test)	100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods
LY2940680 Tablet Fasted + PPI (Part B)	Lansoprazole	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs	Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)	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.
Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1): 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.
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Dallas, Texas, United States