A Study of LY2940680 in Healthy Participants - Full Text View

Purpose

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 people. 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 on LY2940680 will be studied. Part B will involve one group of participants who will take four single doses of 100 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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: LY2940680 Capsule(s) (Reference) Drug: LY2940680 Tablet (Test) Drug: Lanzoprazole Drug: Placebo Capsule(s)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	A Single Ascending Dose and Relative Bioavailability Study of LY2940680 in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of Participants with One or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline through study completion (estimated at 5 weeks) ] [ Designated as safety issue: Yes ]
Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) [ Time Frame: Predose up to 120 hours after administration of study drug ] [ Designated as safety issue: No ]
Pharmacokinetics: Time of Cmax (tmax) [ Time Frame: Predose up to 120 hours after administration of study drug ] [ Designated as safety issue: No ]
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]) [ Time Frame: Predose up to 120 hours after administration of study drug ] [ Designated as safety issue: No ]
Pharmacokinetics: AUC from Zero to Infinity (AUC[0-∞]) [ Time Frame: Predose up to 120 hours after administration of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	September 2012
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) 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 (proton pump inhibitor [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: Lanzoprazole Administered orally as a capsule

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681186

Locations

United States, Texas
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01681186 History of Changes
Other Study ID Numbers:	14893, I4J-MC-HHBG
Study First Received:	September 4, 2012
Last Updated:	January 11, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013