NCT02641899

Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs

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 Drug/Drug Interaction (DDI) Probe Compounds

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Intarcia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ITCA 650 20/60 mcg/day	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.
DRUG	Acetaminophen	Oral acetaminophen 1000 mg on Day 1 and Day 27
DRUG	Atorvastatin	Oral atorvastatin 40 mg on Day 2 and Day 28
DRUG	Lisinopril	Oral lisinopril 20 mg on Day 2 and Day 28
DRUG	Warfarin	Oral warfarin 25 mg on Day 2 and Day 28
DRUG	Digoxin	Oral digoxin 0.5 mg on Day 2 and Day 28

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-12-30
• Last updated: 2017-01-27

Locations

1 site across 1 country: United States