A Study of LY3154207 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: LY3154207; Drug: Placebo; Drug: Itraconazole

• Registration Number: NCT02365571
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-19
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3154207 (Part A)	LY3154207	LY3154207 administered in ascending doses once orally in two of three study periods
Placebo (Part B)	Placebo	Placebo matching LY3154207 administered once orally.
LY3154207 (Part B)	LY3154207	LY3154207 administered once orally.
Placebo (Part A)	Placebo	Placebo matching LY3154207 administered once orally in one of three study periods.
LY3154207 + Itraconazole (Part C)	LY3154207	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.
LY3154207 (Part C)	LY3154207	LY3154207 administered once orally on Day 1
LY3154207 + Itraconazole (Part C)	Itraconazole	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 A : Maximum Drug Concentration (Cmax) of LY3154207	Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole	Predose through 96 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

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States