The purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a single dose with continuous infusion of U-500R insulin, both administered just under the skin. Participants who complete Part A will continue into Part B where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks including initial screening and follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
11
Profil Institute for Clinical Research
Chula Vista, California, United States
Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R
Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R.
Time frame: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose
Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R
Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC\[0-24\]) of U-500R.
Time frame: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose
Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R.
Time frame: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose
Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R
Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R.
Time frame: Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose
Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R
Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC\[0-tlast\]) of U-500R.
Time frame: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose
Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R
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Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R.
Time frame: Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose
Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R
Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R.
Time frame: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose
Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R
Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R.
Time frame: Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose
Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R
Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R.
Time frame: Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose