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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03942029
Other study ID # 16304
Secondary ID I7S-MC-HBEF
Status Completed
Phase Phase 1
First received
Last updated
Start date June 21, 2019
Est. completion date December 28, 2019

Study information

Verified date January 15, 2020
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 28, 2019
Est. primary completion date December 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3154207 Capsule
Administered orally as capsule
LY3154207 Tablet
Administered orally as tablet
Placebo
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet

Locations

Country Name City State
United States Covance Clinical Research Inc Daytona Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to 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 Baseline up to 11 weeks
Secondary Change from Baseline in Blood Pressure (BP) BP measured by ambulatory blood pressure monitoring (ABPM) Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
Secondary Change from Baseline in Pulse Rate (PR) PR measured by ABPM Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
Secondary Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207 PK: Cmax of LY3154207 Baseline up to 48 hours postdose
Secondary 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 PK: AUC(0-tlast) of LY3154207 Baseline up to 48 hours postdose
Secondary PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207 PK: AUC(0-inf) of LY3154207 Baseline up to 48 hours postdose
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