Clinical trial NCT02365571: A Study of LY3154207 in Healthy Participants
Official title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Cytochrome P450 Interaction Study of LY3154207 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Up to 48 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole
timeFrame: Predose through 96 hours after administration of study drug
measure: Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole
timeFrame: Predose through 96 hours after administration of study drug
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: