A Study of LY3323795 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3323795; Drug: Itraconazole

• Registration Number: NCT02989389
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to investigate the safety of LY3323795 and the effects it has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy participants. The study has three parts. Each participant may only enroll in one part. The study will last 14 to 43 days, depending on the part. Screening must be completed prior to study start.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-08
• Study Start: 2016-12-12
• Study First Posted: 2016-12-12
• Primary Completion: 2017-07-21
• Study Completion: 2017-07-21
• Results First Submitted: 2020-03-09
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-09
• Results First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Healthy males or females of non-childbearing potential at time of screening
• Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0 kg/m², inclusive

Exclusion Criteria

• Have participated, within the last 30 days, in a clinical trial involving an investigational product.
• Have a QT corrected for heart rate (QTc) (using Bazett's formula) interval value of greater than 450 millisecond (msec) (males) or greater than 470 msec (females)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Part B)	Placebo	Participants received placebo identical to LY3323795 orally.
LY3323795 (Part C)	LY3323795	Part C was not initiated due to a Lilly internal strategy decision.
Placebo (Part A)	Placebo	Participants received placebo identical to LY3323795 orally.
LY3323795 (Part A)	LY3323795	Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally.
LY3323795 (Part B)	LY3323795	Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally.
LY3323795 + Itraconazole (Part C)	LY3323795	Part C was not initiated due to a Lilly internal strategy decision.
LY3323795 + Itraconazole (Part C)	Itraconazole	Part C was not initiated due to a Lilly internal strategy decision.

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	Baseline to Study Completion (up to Day 43)	Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma	0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose	Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.
Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)	-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose	Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma	0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose	Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC\[0-tlast\]) of LY3323795 in plasma.
Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)	-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose	Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC\[0-tlast\]) of LY3323795 in cerebrospinal fluid (CSF).
Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂	Baseline through 144 hours	Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.
Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂	Baseline through 36 hours	Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.

Trial Locations

Locations (1)

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States