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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 Glucagon Formulation in Otherwise Healthy Subjects
The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in participants with a common cold, some of whom will also take a nasal decongestant. The study will investigate how the body processes NG and the effect of NG on the body. The study will last up to 30 days for each participant.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2013-03 |
| Completion | 2013-04 |
Conditions
- Common Cold
Interventions
- Nasal Glucagon
- Oxymetazoline
Primary outcomes
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) — Baseline up to Study Completion (Day 30)
Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation participant administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Countries
Canada