A Phase 1 interventional study of LY3556050 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive single ascending doses of LY3556050 orally.
Drug: LY3556050
Participants will receive placebo orally.
Drug: Placebo
Participants will receive multiple ascending doses of LY3556050 orally.
Drug: LY3556050
Participants will receive placebo orally.
Drug: Placebo
Administered orally.
Also known as: CNTX-0290
Administered orally.
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
Time frame: Baseline through Day 30
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)
PK: 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: 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)
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: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1)
PK: fe\[0-48\] of LY3556050 (Part 1)
Time frame: 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)
Time frame: 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)
Time frame: Predose up to Postdose on Day 10
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company