A Study of LY3323795 in Healthy Participants

NCT02989389 | Completed Phase 1 Results

• 2 other identifiers: 16610I9F-MC-SCAA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  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.

  Baseline to Study Completion (up to Day 43)

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂

  Baseline through 144 hours

Study Arms (6)

LY3323795 (Part A)

EXPERIMENTAL

Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally.

Drug: LY3323795

Placebo (Part A)

PLACEBO COMPARATOR

Participants received placebo identical to LY3323795 orally.

Drug: Placebo

LY3323795 (Part B)

EXPERIMENTAL

Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally.

Drug: LY3323795

Placebo (Part B)

PLACEBO COMPARATOR

Participants received placebo identical to LY3323795 orally.

Drug: Placebo

LY3323795 (Part C)

EXPERIMENTAL

Part C was not initiated due to a Lilly internal strategy decision.

Drug: LY3323795

LY3323795 + Itraconazole (Part C)

EXPERIMENTAL

Part C was not initiated due to a Lilly internal strategy decision.

Drug: LY3323795; Drug: Itraconazole

Interventions

LY3323795 DRUG

Administered orally

LY3323795 (Part A); LY3323795 (Part B); LY3323795 (Part C); LY3323795 + Itraconazole (Part C)

Itraconazole DRUG

Administered orally

LY3323795 + Itraconazole (Part C)

Placebo DRUG

Administered orally

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91260, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Limitations and Caveats

Part C (an itraconazole interaction study) was not initiated due to a Lilly internal strategy decision.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: December 12, 2016
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)