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

NCT02641899 · Completed

Last updated 2026-05-28

This clinical trial tested how ITCA 650 affects the absorption of acetaminophen and three other common medications in healthy adults.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design open-label (no blinding) study

Participants 33 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2015-12 · est. completion 2016-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT02641899 ↗

Description as written by the study sponsor.

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.

Treatments tested

ITCA 650 20/60 mcg/day Drug

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.
Acetaminophen Drug

Oral acetaminophen 1000 mg on Day 1 and Day 27
Atorvastatin Drug

Oral atorvastatin 40 mg on Day 2 and Day 28
Lisinopril Drug

Oral lisinopril 20 mg on Day 2 and Day 28
Warfarin Drug

Oral warfarin 25 mg on Day 2 and Day 28
Digoxin Drug

Oral digoxin 0.5 mg on Day 2 and Day 28

Main thing measured	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.
Sponsor	Intarcia Therapeutics
Conditions studied	Healthy
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02641899 ↗