A Study of Single and Repeated Doses of LY3556050 in Healthy Participants

April 18, 2022 updated by: Eli Lilly and Company

A Study to Evaluate the Safety and Pharmacokinetics of Single and Repeated Doses of CNTX-0290 in Healthy Subjects

The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in the bloodstream and to determine if any age, gender, or food effects exist. The study will also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing doses of LY3556050 will be given orally and participants will be confined for a 5-day period. In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will be confined for a 14-day period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Medpace Clinical Pharmacology, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation.
  • Participants with a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²) and have body weight of 50 kg or more.

Exclusion Criteria:

  • Has any history of or active cardiac disease, including congestive heart failure, angina, any arrhythmia, or clinically significant findings on Electrocardiogram (ECG).
  • Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy.
  • Has asthma or other severe respiratory disease.
  • Is pregnant, lactating, or planning a pregnancy.
  • Has active alcohol or substance abuse or history of alcohol or substance abuse within the 6 months prior to randomization.
  • Any abnormal laboratory finding or vital signs outside specified parameters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: LY3556050 (Part 1)
Participants will receive single ascending doses of LY3556050 orally.
Drug: LY3556050
Administered orally.
Other Names:
  • CNTX-0290
EXPERIMENTAL: Placebo (Part 1)
Participants will receive placebo orally.
Drug: Placebo
Administered orally.
EXPERIMENTAL: LY3556050 (Part 2)
Participants will receive multiple ascending doses of LY3556050 orally.
Drug: LY3556050
Administered orally.
Other Names:
  • CNTX-0290
EXPERIMENTAL: Placebo (Part 2)
Participants will receive placebo orally.
Drug: Placebo
Administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline through Day 30
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline through Day 30
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)
Time Frame: Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)
PK: Cmax of LY3556050 (Part 1)
Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3556050 (Part 1)
Time Frame: Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)
PK: AUC[0-∞] of LY3556050 (Part 1)
Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)
PK: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1)
Time Frame: Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7)
PK: fe[0-48] of LY3556050 (Part 1)
Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7)
PK: Cmax of LY3556050 (Part 2)
Time Frame: Predose up to Postdose on Day 10
PK: Cmax of LY3556050 (Part 2)
Predose up to Postdose on Day 10
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3556050 (Part 2)
Time Frame: Predose up to Postdose on Day 10
PK: AUC[0-24] of LY3556050 (Part 2)
Predose up to Postdose on Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18327 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • J2P-MC-LXBB (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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