A Study of LY2940680 in Healthy Participants

NCT01681186 | Completed Phase 1 Results

• 2 other identifiers: 14893I4J-MC-HHBG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• 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)

  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)]

  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)]

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug

Study Arms (6)

LY2940680 (Part A)

EXPERIMENTAL

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)

Placebo (Part A)

PLACEBO COMPARATOR

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

Drug: Placebo Capsule(s)

LY2940680 Capsule Fasted (Part B)

EXPERIMENTAL

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)

LY2940680 Tablet Fasted (Part B)

EXPERIMENTAL

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

Drug: LY2940680 Tablet (Test)

LY2940680 Tablet Fed (Part B)

EXPERIMENTAL

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)

LY2940680 Tablet Fasted + PPI (Part B)

EXPERIMENTAL

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); Drug: Lansoprazole

Interventions

LY2940680 Capsule(s) (Reference) DRUG

Administered orally as a capsule(s)

LY2940680 (Part A); LY2940680 Capsule Fasted (Part B)

LY2940680 Tablet (Test) DRUG

Administered orally as a tablet

LY2940680 Tablet Fasted (Part B); LY2940680 Tablet Fasted + PPI (Part B); LY2940680 Tablet Fed (Part B)

Lansoprazole DRUG

Administered orally as a capsule

LY2940680 Tablet Fasted + PPI (Part B)

Placebo Capsule(s) DRUG

Administered orally as a capsule(s)

Placebo (Part A)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Dallas, Texas, United States

Location

MeSH Terms

Interventions

LY2940680; Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)