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Completed

NCT Number: NCT03942029

A Drug Interaction Study of LY3154207 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3154207 Capsule

Drug

Administered orally as capsule

LY3154207 Tablet

Drug

Administered orally as tablet

Placebo

Drug

Administered orally as tablet

Other names: Placebo Tablet

Fluconazole Tablet

Drug

Administered orally as tablet

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

    Time frame: Baseline up to 11 weeks

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Change from Baseline in Blood Pressure (BP)

    Time frame: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole

    BP measured by ambulatory blood pressure monitoring (ABPM)

  2. Change from Baseline in Pulse Rate (PR)

    Time frame: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole

    PR measured by ABPM

  3. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207

    Time frame: Baseline up to 48 hours postdose

    PK: Cmax of LY3154207

  4. 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

    Time frame: Baseline up to 48 hours postdose

    PK: AUC(0-tlast) of LY3154207

  5. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207

    Time frame: Baseline up to 48 hours postdose

    PK: AUC(0-inf) of LY3154207

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 8, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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