| Trial ID: | L0292 |
| Source ID: | NCT01237899
|
| Associated Drug: |
Ly2623091
|
| Title: |
Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01237899/results
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: LY2623091|DRUG: Placebo|DRUG: Eplerenone
|
| Outcome Measures: |
Primary: Number of Participants With Clinically Significant Effects (Adverse Events), A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section., Baseline through 7 days for each treatment period | Secondary: Pharmacodynamics: Serum to Urine Potassium Area Under the Concentration-Time Curve (AUC) Standardized for Urinary Excretion at Day 7, A measure of the renal clearance of the potassium ion (K+). The Least Squares (LS) Mean value was adjusted for pre-challenge renal K+ clearance., Day 7: 24 Hour (hr), 48hr and 72hr Postdose|Pharmacokinetics of LY2623091: Maximal Concentration (Cmax) at Day 6, Cmax estimated for LY2623091., Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose|Pharmacokinetics LY2623091: Area Under the Concentration-Time Curve (AUC) at Day 6, AUC from time 0, extrapolated to infinity, estimated for LY2623091., Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2010-10
|
| Completion Date: |
2011-01
|
| Results First Posted: |
2019-06-03
|
| Last Update Posted: |
2019-06-03
|
| Locations: |
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., Zuidlaren, 9471 GP, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT01237899
|
