A Study of LY3154207 in Healthy Participants

NCT02365571 | Completed Phase 1

• 2 other identifiers: 15510I7S-EW-HBEA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study. Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed. Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207. Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant. Participants may only enroll in 1 of the 3 parts of the study.

Conditions

Healthy Participants

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 Administration

  Up to 48 hours after administration of study drug

Secondary Outcomes (6)

• Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207

  Predose through 48 hours after administration of study drug

• Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207

  Predose through 48 hours after administration of study drug

• Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207

  Predose through 48 hours after administration of study drug

• Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207

  Predose through 48 hours after administration of study drug

• Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole

  Predose through 96 hours after administration of study drug

Study Arms (6)

LY3154207 (Part A)

EXPERIMENTAL

LY3154207 administered in ascending doses once orally in two of three study periods

Drug: LY3154207

Placebo (Part A)

PLACEBO COMPARATOR

Placebo matching LY3154207 administered once orally in one of three study periods.

Drug: Placebo

LY3154207 (Part B)

EXPERIMENTAL

LY3154207 administered once orally.

Drug: LY3154207

Placebo (Part B)

PLACEBO COMPARATOR

Placebo matching LY3154207 administered once orally.

Drug: Placebo

LY3154207 (Part C)

EXPERIMENTAL

LY3154207 administered once orally on Day 1

Drug: LY3154207

LY3154207 + Itraconazole (Part C)

EXPERIMENTAL

Itraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A.

Drug: LY3154207; Drug: Itraconazole

Interventions

LY3154207 DRUG

Administered orally

LY3154207 (Part A); LY3154207 (Part B); LY3154207 (Part C); LY3154207 + Itraconazole (Part C)

Placebo DRUG

Administered orally

Placebo (Part A); Placebo (Part B)

Itraconazole DRUG

Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution

LY3154207 + Itraconazole (Part C)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy males or females, as determined by medical history and physical examination
• Female participants not of child-bearing potential
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Have given written informed consent
• Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m\^2)

You may not qualify if:

• Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
• Part C only: Have known allergy or contraindications to itraconazole

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

LY3154207; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

US (1)