A Study of LY3154207 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365571
• Other study ID #: 15510
• Secondary ID: I7S-EW-HBEA
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2015
• Last updated: June 9, 2015
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207		Predose through 48 hours after administration of study drug	No
Secondary	Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207		Predose through 48 hours after administration of study drug	No
Secondary	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	No
Secondary	Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207		Predose through 48 hours after administration of study drug	No
Secondary	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	No
Secondary	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	No