A Phase 1, Fixed-Sequence, Open-label Study in Healthy Subjects to Estimate the Effects of ITCA 650 on Gastric Emptying and on the Absorption Pharmacokinetics of Each of 4 Commonly Studied DDI Probe Compounds.
Acetaminophen will be use to assess the effect of ITCA 650 on the rate of gastric emptying. Interactions between ITCA 650 and the medications lisinopril, digoxin, atorvastatin, and warfarin will also be studied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
33
ITCA 650 osmotic mini pump delivering exenatide 20 mcg/day for 14 days, followed by ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day.
Oral acetaminophen 1000 mg on Day 1 and Day 27
Oral atorvastatin 40 mg on Day 2 and Day 28
Quintiles
Overland Park, Kansas, United States
Area under the concentration-time curve from time zero to the last measurable concentration [AUC(0-last)]) of acetaminophen alone and in the presence of ITCA 650.
Time frame: time zero to 10 weeks
Maximum plasma concentration ([Cmax]) of acetaminophen alone and in the presence of ITCA 650
Time frame: time zero to 10 weeks
Area under the concentration-time curve (AUC(0-last)) of atorvastatin, lisinopril, digoxin, R-warfarin, and S-warfarin each alone and in the presence of ITCA 650.
Time frame: time zero to 10 weeks
Cmax of atorvastatin, lisinopril, digoxin, R-warfarin, and S-warfarin each alone and in the presence of ITCA 650.
Time frame: time zero to 10 weeks
Time to maximum plasma concentration (tmax) of acetaminophen
Time frame: time zero to 10 weeks
tmax of atorvastatin, lisinopril, digoxin, R warfarin, and S-warfarin
Time frame: time zero to 10 weeks
AUC(0-last) of orthohydroxy-atorvastatin and parahydroxy-atorvastatin
Time frame: time zero to 10 weeks
Cmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin
Time frame: time zero to 10 weeks
Maximum effect (Emax)from time zero to the last measurable concentration (AUEC(0-last)) of international normalized ratio (INR) of warfarin.
Time frame: time zero to 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oral lisinopril 20 mg on Day 2 and Day 28
Oral warfarin 25 mg on Day 2 and Day 28
Oral digoxin 0.5 mg on Day 2 and Day 28
Cmax of ITCA 650, 20 mcg/d and 60 mcg/d
Time frame: within 8 hours after placement of ITCA 650
Treatment-emergent adverse events (TEAEs) including any events local to the placement site, clinical laboratory measurements, ECGs, vital signs and physical examinations.
Time frame: time zero to 10 weeks
Tmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin
Time frame: time zero to 10 weeks
Cmin of ITCA 650, 20 mcg/d and 60 mcg/d
Time frame: time zero to 10 weeks
Tmax of ITCA 650, 20 mcg/d and 60 mcg/d
Time frame: time zero to 10 weeks
Tmin of ITCA 650, 20 mcg/d and 60 mcg/d
Time frame: zero to 10 weeks
Time of maximum effect (tEmax)from time zero to the last measurable concentration (AUEC(0-last)) of international normalized ratio (INR) of warfarin.
Time frame: zero to 10 weeks
Area under the effect-time curve from time zero to the last measurable concentration (AUEC(0-last)) of international normalized ratio (INR) of warfarin.
Time frame: zero to 10 weeks