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Probe Drug Cocktail

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

Probe Drug Cocktail · 1 trial · 1 indication

Phase 1 1
NCT03252015A Study of Multiple Doses of Lasmiditan in Healthy ParticipantsHealthy
COMPLETED70 Analytics
PHASE1COMPLETED
A Study of Multiple Doses of Lasmiditan in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through 14 days after last administration of study drug

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.

Secondary Endpoints

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Probe Drug Cocktail (Cohort 1a)EXPERIMENTALProbe Drug Cocktail administered orally on Day -3.
200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)EXPERIMENTAL200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
Placebo+Probe Drug Cocktail (Cohort 1b)PLACEBO_COMPARATORPlacebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
400 mg Lasmiditan (Cohort 2a)EXPERIMENTAL400 mg lasmiditan administered orally for 7 days.
Placebo (Cohort 2b)EXPERIMENTALPlacebo administered orally for 7 days.

Interventions

NameTypeDescription
Probe Drug CocktailDRUGAdministered orally
LasmiditanDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening Exclusion Criteria: * Have participated, within the last 30 days, in a c...

Countries:United States
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Frequently asked questions about Probe Drug Cocktail

What is Probe Drug Cocktail used for?

Probe Drug Cocktail is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a completed trial involving 70 participants in the United States. The drug is being evaluated for use in healthy individuals as part of early-stage research.

Who makes Probe Drug Cocktail?

Probe Drug Cocktail is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy participants.

What phase is Probe Drug Cocktail in?

Probe Drug Cocktail is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials. One Phase 1 study has been completed, involving 70 healthy participants in the United States.

What clinical trials is Probe Drug Cocktail in?

Probe Drug Cocktail has one completed clinical trial, registered as NCT03252015, titled "A Study of Multiple Doses of Lasmiditan in Healthy Participants." This Phase 1 study enrolled 70 healthy participants in the United States and was a randomized, double-blind, placebo-controlled trial.

Is Probe Drug Cocktail the same as Lasmiditan?

Probe Drug Cocktail is associated with the drug lasmiditan, as indicated by the clinical trial title NCT03252015, which studied multiple doses of lasmiditan in healthy participants. The trial was conducted by Eli Lilly and Company, the developer of Probe Drug Cocktail.