Clinical trial NCT02018887: A Study of LY2969822 in Healthy Participants
Official title: A Single- and Multiple-Ascending Dose, Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Study of LY2969822 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Participants in Part A will complete three study periods, which together will last about 40 days. Participants in Parts B and C will complete one study period which will last about 17 days, but the total study time is about 40 days. Each participant may only enroll in one part. Screening is required within 28 days prior to the start of the study for all participants.

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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline Through End of Study (up to Week 7)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
timeFrame: All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
measure: PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
timeFrame: Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
measure: PK: Area Under the Drug Plasma Concentration Time Curve (Plasma AUC) of Prodrug LY2969822 and Active Metabolite LSN2934747
timeFrame: All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
measure: PK: CSF AUC(Tau) of Prodrug LY2969822 and Active Metabolite LSN2934747
timeFrame: Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: