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Healthy ParticipantsPhase 1NCT01681186

A Study of LY2940680 in Healthy Participants

A Phase 1 study testing LY2940680 Capsule(s) (Reference), LY2940680 Tablet (Test) and Lansoprazole in people with Healthy Participants, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
LY2940680 Capsule(s) (Reference), LY2940680 Tablet (Test) and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Sep 2012to Dec 2012
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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  • Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product.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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • 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

Other trials in United States

About this study

Official title: 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.

Being tested
LY2940680 Capsule(s) (Reference), LY2940680 Tablet (Test), Lansoprazole, Placebo Capsule(s)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2940680 Capsule(s) (Reference)Drug

    Administered orally as a capsule(s)

  • LY2940680 Tablet (Test)Drug

    Administered orally as a tablet

  • LansoprazoleDrug

    Administered orally as a capsule

  • Placebo Capsule(s)Drug

    Administered orally as a capsule(s)

Study groups in NCT01681186
Study groupRoleWhat they receive
LY2940680 (Part A)ExperimentalSingle escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods
Receives: Drug: LY2940680 Capsule(s) (Reference)
Placebo (Part A)Placebo comparatorPlacebo given once orally in up to 1 of 2 study periods
Receives: Drug: Placebo Capsule(s)
LY2940680 Capsule Fasted (Part B)Experimental100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods
Receives: Drug: LY2940680 Capsule(s) (Reference)
LY2940680 Tablet Fasted (Part B)Experimental100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods
Receives: Drug: LY2940680 Tablet (Test)
LY2940680 Tablet Fed (Part B)Experimental100 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
Receives: Drug: LY2940680 Tablet (Test)
LY2940680 Tablet Fasted + PPI (Part B)Experimental30 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
Receives: Drug: LY2940680 Tablet (Test); Drug: Lansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)

  2. 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.

    Measured: 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)

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

    The Cmax of LY2940680 during Part A of the study was reported.

    Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

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

    Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)

    Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

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

    Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)

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

  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)]

    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)]

    Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

  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)]

    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)]

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

  6. 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-∞)]

    Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

  7. 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-∞)]

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01681186
Sponsor's protocol ID
14893
Other IDs
I4J-MC-HHBG
Status last verified
Sep 2019
First submitted
4 Sep 2012
Last updated
21 Oct 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2940680 Capsule(s) (Reference), LY2940680 Tablet (Test) and Lansoprazole in people with Healthy Participants, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01681186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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