A Study of LY2886721 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534273
• Other study ID #: 14464
• Secondary ID: I4O-MC-BACJ
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Healthy men and non-childbearing potential women

• Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2)

• Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

• Taking over-the-counter or prescription medication with the exception of vitamins or minerals

• Smoke more than 10 cigarettes per day

• Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2886721
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	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.	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinically Significant Effects	Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.	Predose up to Day 23
Secondary	Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721		Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose
Secondary	Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721		Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose
Secondary	Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721		Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose
Secondary	Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721	AUC over the dosing interval at steady state (AUCtau,ss) is reported for participants who received multiple doses of LY2886721.	Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose
Secondary	Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15	Least squares (LS) mean percent changes from baseline to Day 15 in CSF amyloid 1-40 concentrations for participants in Cohort B are reported. LS means were calculated from an analysis of covariance (ANCOVA) with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% confidence interval (CI) of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline.	Baseline, Day 15
Secondary	Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose	LS mean percent changes from baseline to 24 hours post-dose in CSF amyloid 1-40 concentrations for participants in Cohort C are reported. LS means were calculated from an ANCOVA with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% CI of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline.	Baseline, 24 hours post-dose