Clinical trial NCT03942029: A Drug Interaction Study of LY3154207 in Healthy Participants
Official title: Safety and Tolerability of LY3154207 in Combination With a CYP3A4 Inhibitor and Assessment of Pharmacokinetics of LY3154207 After Administration of Capsule and Tablet Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²)
* Have clinical laboratory test results within acceptable range for the population

Exclusion Criteria:

* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
* Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study
* Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study
* Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of \< 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline up to 11 weeks
Secondary outcomes:
measure: Change from Baseline in Blood Pressure (BP)
timeFrame: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
measure: Change from Baseline in Pulse Rate (PR)
timeFrame: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207
timeFrame: Baseline up to 48 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207
timeFrame: Baseline up to 48 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207
timeFrame: Baseline up to 48 hours postdose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: