Phase 1
Completed N=42
A Study of LY3323795 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02989389 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma |
0.503; 1.77; 4.79; 15.7; 34.6; 89.1 | — |
| SECONDARY Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF) |
0.293; 0.788; 2.86 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma |
5.67; 25.2; 73.4; 274; 663; 2370 | — |
| SECONDARY Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF) |
5.46; 13.7; 55.1 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂ |
-39; -52; -71; -76; -76; -89 | — |
| SECONDARY Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂ |
-51; -69; -88; -12; -37; -71 | 0.215 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02989389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.