Skip to main content
OpenTrials
Completed

NCT Number: NCT01681186

A Study of LY2940680 in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary 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, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product.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

Treatment and study plan

LY2940680 Capsule(s) (Reference)

Drug

Administered orally as a capsule(s)

LY2940680 Tablet (Test)

Drug

Administered orally as a tablet

Lansoprazole

Drug

Administered orally as a capsule

Placebo Capsule(s)

Drug

Administered orally as a capsule(s)

Primary outcomes

  1. Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs

    Time frame: 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.

  2. Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation

    Time frame: 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 outcomes

  1. Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)

    Time frame: 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.

  2. Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)

    Time frame: 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)

  3. Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)

    Time frame: 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)

  4. 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)]

    Time frame: 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)]

  5. 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)]

    Time frame: 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)]

  6. Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]

    Time frame: 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-∞)]

  7. Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]

    Time frame: 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-∞)]

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2012
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.