HealthyPhase 1NCT05341102
A Study of Single and Repeated Doses of LY3556050 in Healthy Participants
A Phase 1 study testing LY3556050 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3556050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2016to 2 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology, LLC
Cincinnati, Ohio, 45227
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- LY3556050, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3556050Drug
Also called CNTX-0290
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3556050 (Part 1) | Experimental | Participants will receive single ascending doses of LY3556050 orally. Receives: Drug: LY3556050 |
| Placebo (Part 1) | Experimental | Participants will receive placebo orally. Receives: Drug: Placebo |
| LY3556050 (Part 2) | Experimental | Participants will receive multiple ascending doses of LY3556050 orally. Receives: Drug: LY3556050 |
| Placebo (Part 2) | Experimental | Participants will receive placebo orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Day 30
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)
PK: Cmax of LY3556050 (Part 1)
Measured: 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)
PK: AUC[0-∞] of LY3556050 (Part 1)
Measured: 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)
PK: fe[0-48] of LY3556050 (Part 1)
Measured: 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)
PK: Cmax of LY3556050 (Part 2)
Measured: 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)
PK: AUC[0-24] of LY3556050 (Part 2)
Measured: Predose up to Postdose on Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start14 Sep 2016
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341102
- Sponsor's protocol ID
- 18327
- Other IDs
- J2P-MC-LXBB
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Pharmacokinetics of Single and Repeated Doses of CNTX-0290 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05341102
- Acronym / sponsor ID
- 18327
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3556050 (Part 1) | Experimental | Drug: LY3556050Participants will receive single ascending doses of LY3556050 orally. |
| Placebo (Part 1) | Experimental | Drug: PlaceboParticipants will receive placebo orally. |
| LY3556050 (Part 2) | Experimental | Drug: LY3556050Participants will receive multiple ascending doses of LY3556050 orally. |
| Placebo (Part 2) | Experimental | Drug: PlaceboParticipants will receive placebo orally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3556050Also: CNTX-0290Administered orally. | Drug | LY3556050 (Part 1), LY3556050 (Part 2) |
| PlaceboAdministered orally. | Drug | Placebo (Part 1), Placebo (Part 2) |
Primary outcome
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
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)
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)
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)
PK: Cmax of LY3556050 (Part 2)
Time frame: Predose up to Postdose on Day 10
PK: Cmax of LY3556050 (Part 2)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3556050 in people with Healthy, 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 2 inclusion and 6 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 22 Apr 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.