A Study of LY2886721 in Healthy Participants
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01534273
First received: February 13, 2012
Last updated: August 9, 2012
Last verified: August 2012
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Purpose
The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, how the body handles the drug and the drug's effect on the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: LY2886721 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects |
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Number of participants with clinically significant effects [ Time Frame: Predose up to Day 23 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics: Plasma maximum observed concentration at steady state (Cmax,ss) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
- Pharmacokinetics: Plasma area under the concentration versus time curve (AUC) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
- Change from baseline in cerebrospinal fluid (CSF) amyloid 1-40 concentration at Day 15 [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]
- Change from baseline in cerebrospinal fluid (CSF) amyloid 1-40 concentration at 24 hours post-dose [ Time Frame: Baseline, 24 hours post-dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 39 |
| Study Start Date: | February 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Single oral dose and/or once daily oral dosing for 14 consecutive days
|
Drug: Placebo
Administered orally.
|
|
Experimental: 35 mg LY2886721
Once daily oral dosing for 14 consecutive days
|
Drug: LY2886721
Administered orally.
|
|
Experimental: 70 mg LY2886721
Single oral dose followed by once daily oral dosing for 14 consecutive days
|
Drug: LY2886721
Administered orally.
|
|
Experimental: 140 mg LY2886721
Single oral dose
|
Drug: LY2886721
Administered orally.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy men and non-childbearing potential women
- Body mass index between 18.0-32.0 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 (e.g., coffee, tea) per day
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534273
Locations
| United States, California | |
| 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, United States, 91206 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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 |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01534273 History of Changes |
| Other Study ID Numbers: | 14464, I4O-MC-BACJ |
| Study First Received: | February 13, 2012 |
| Last Updated: | August 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Mild Cognitive Impairment |
ClinicalTrials.gov processed this record on May 23, 2013