NCT03942029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2019

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 21, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 15, 2020

Enrollment Period

6 months

First QC Date

May 7, 2019

Last Update Submit

January 16, 2020

Conditions

Healthy

Outcome Measures

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

    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 Outcomes (5)

  • Change from Baseline in Blood Pressure (BP)

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

  • Change from Baseline in Pulse Rate (PR)

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

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207

    Baseline up to 48 hours postdose

  • 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

    Baseline up to 48 hours postdose

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

    Baseline up to 48 hours postdose

Study Arms (8)

Cohort 1 Part A - LY3154207 Capsule

EXPERIMENTAL

LY3154207 capsule (reference) administered orally, once.

Drug: LY3154207 Capsule

Cohort 1 Part A - LY3154207 Tablet

EXPERIMENTAL

LY3154207 tablet (test) administered orally, once.

Drug: LY3154207 Tablet

Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole

EXPERIMENTAL

LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.

Drug: LY3154207 TabletDrug: Fluconazole Tablet

Cohort 1 Part B - Placebo + Fluconazole

EXPERIMENTAL

Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.

Drug: PlaceboDrug: Fluconazole Tablet

Cohort 2 - LY3154207 (Dose 2) + Fluconazole

EXPERIMENTAL

LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.

Drug: LY3154207 TabletDrug: Fluconazole Tablet

Cohort 2 - Placebo + Fluconazole

EXPERIMENTAL

Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.

Drug: PlaceboDrug: Fluconazole Tablet

Cohort 3 - LY3154207 + Fluconazole

EXPERIMENTAL

LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.

Drug: LY3154207 TabletDrug: Fluconazole Tablet

Cohort 3 - Placebo + Fluconazole

EXPERIMENTAL

Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.

Drug: PlaceboDrug: Fluconazole Tablet

Interventions

LY3154207 CapsuleDRUG

Administered orally as capsule

Cohort 1 Part A - LY3154207 Capsule
LY3154207 TabletDRUG

Administered orally as tablet

Cohort 1 Part A - LY3154207 TabletCohort 1 Part B LY3154207 (Dose 1) + FluconazoleCohort 2 - LY3154207 (Dose 2) + FluconazoleCohort 3 - LY3154207 + Fluconazole
PlaceboDRUG

Administered orally as tablet

Also known as: Placebo Tablet
Cohort 1 Part B - Placebo + FluconazoleCohort 2 - Placebo + FluconazoleCohort 3 - Placebo + Fluconazole
Fluconazole TabletDRUG

Administered orally as tablet

Cohort 1 Part B - Placebo + FluconazoleCohort 1 Part B LY3154207 (Dose 1) + FluconazoleCohort 2 - LY3154207 (Dose 2) + FluconazoleCohort 2 - Placebo + FluconazoleCohort 3 - LY3154207 + FluconazoleCohort 3 - Placebo + Fluconazole

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

LY3154207Fluconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The capsule versus tablet formulation comparison will be open label.
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 8, 2019

Study Start

June 21, 2019

Primary Completion

December 28, 2019

Study Completion

December 28, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01-15

Data Sharing

IPD Sharing
Will not share

Locations

US(1)