Phase 1
Completed N=18
A Study of LY2969822 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02018887 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 participants
Summary
The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747 |
19.9; 209; 346; 63.3; 646; 197 | — |
| SECONDARY PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747 |
NA; 8.42; NA; 93.0 | — |
| SECONDARY PK: Area Under the Drug Plasma Concentration Time Curve (Plasma AUC) of Prodrug LY2969822 and Active Metabolite LSN2934747 |
88.5; 843; 1730; 273; 3700; 1110 | — |
| SECONDARY PK: CSF AUC(Tau) of Prodrug LY2969822 and Active Metabolite LSN2934747 |
NA; 75.1; NA; 831 | — |
Eligibility Criteria
Inclusion Criteria
- Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2969822
- Female participants must not be of child-bearing potential
- Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m^2), inclusive, at screening
Exclusion Criteria
- Have participated, within the last 30 days (prior to first dose in this study), in a clinical trial involving an investigational product
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Intended use of over-the-counter medication within 14 days prior to dosing or during the study with the exception of vitamins and mineral supplements or occasional paracetamol or acetaminophen
- Intended use of herbal supplements or prescription medications, other than stable doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or during the study
Data sourced from ClinicalTrials.gov (NCT02018887). 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.