Phase 1
Completed N=23
A Study of LY3185643 and rGlucagon in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02951780 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon — 191; 658; 1110; 2010 picogram per milliliter (pg/mL)
Summary
The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.
This study will last at least 35 days, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon |
191; 658; 1110; 2010; 3830; 53.7 | — |
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon |
356; 1200; 2230; 4430; 9120; NA | — |
| PRIMARY Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon |
5.54; 15.1; 24.0; 37.1; 53.2; 4.37 | — |
| PRIMARY Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon |
50.2; 201; 324; 555; 969; 25.4 | — |
| PRIMARY Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon |
1.46; 18.9; 29.7; 45.1; 71.5; 0.594 | — |
| PRIMARY Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon |
25.0; 246; 354; 669; 1170; -28.3 | — |
Eligibility Criteria
Inclusion Criteria
- Are overtly healthy as determined by medical history and physical examination
- Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)
Exclusion Criteria
- Have participated, within the last 30 days, in a clinical trial involving an investigational product
- Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
- History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
- Abnormal blood pressure
- History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position
- History of vasovagal response such as fainting
- History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- History of/current insulinoma and/or pheochromocytoma
- Have used systemic glucocorticoids within 3 months before entry into the study
Data sourced from ClinicalTrials.gov (NCT02951780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.