Clinical Trial: A Study of LY900018 in Participants With a Common Cold

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Study to Evaluate the Effects of Common Cold and of Concomitant Administration of Nasal Decongestant on the Pharmacokinetics and Pharmacodynamics of a Novel Gluc

Brief Summary: The main purpose of this study is to evaluate the safety of LY900018 in participants with a common cold, some of whom will also take a nasal decongestant. The study will investigate how the body processes LY900018 and the effect of LY900018 on the body. The study will last up to 30 days for each participant.

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Study Completion (Day 30) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics: Area Under the Curve from Time Zero to the Last Quantifiable Concentration (AUC[0-t]) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  • Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  • Pharmacodynamics: Area Under the Effect Concentration Time Curve (AUEC₀-₃) of Blood Glucose (BG) [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  • Pharmacodynamics: Tmax of BG [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  • Pharmacodynamics: Cmax of BG [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]


Original Secondary Outcome: Same as current

Information By: Eli Lilly and Company

Dates:
Date Received: May 18, 2016
Date Started: March 2013
Date Completion:
Last Updated: May 18, 2016
Last Verified: May 2016