A Study of LY3154207 in Healthy Participants

NCT02365571 — Phase 1, Completed, 64 participants, Eli Lilly and Company

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Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Cytochrome P450 Interaction Study of LY3154207 in Healthy Subjects

Registry	NCT02365571
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: double, basic science
Enrollment	64 (Actual)
Sponsor	Eli Lilly and Company (Industry)
Conditions	Healthy Participants
Interventions	LY3154207, Placebo, Itraconazole (Drug)
Dates	start 2015-02-01, primary completion 2015-05-01, completion 2015-05-01, first posted 2015-02-19, last updated 2015-06-11
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
LY3154207 (Part A)	Experimental	Drug: LY3154207	LY3154207 administered in ascending doses once orally in two of three study periods
Placebo (Part A)	Placebo comparator	Drug: Placebo	Placebo matching LY3154207 administered once orally in one of three study periods.
LY3154207 (Part B)	Experimental	Drug: LY3154207	LY3154207 administered once orally.
Placebo (Part B)	Placebo comparator	Drug: Placebo	Placebo matching LY3154207 administered once orally.
LY3154207 (Part C)	Experimental	Drug: LY3154207	LY3154207 administered once orally on Day 1
LY3154207 + Itraconazole (Part C)	Experimental	Drug: LY3154207; Drug: 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.

LY3154207 (Drug): Administered orally
Placebo (Drug): Administered orally
Itraconazole (Drug): Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution

+Outcome measures

Primary outcomes

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

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]
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]

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
PRA Health Sciences	Salt Lake City, Utah	United States

+Investigators

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), Study director, Eli Lilly and Company