Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects

NCT02320045 · Completed

Last updated 2026-05-28

This clinical trial is testing how a medication called ITCA 650 is absorbed and processed in the body of people with kidney problems compared to people with normal kidney function.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 38 people

Who can join Ages 25–80 · all sexes Healthy volunteers accepted.

Timeline Started 2014-11 · est. completion 2015-07

Where 4 sites · Germany, United States

What this study is testing ClinicalTrials.gov NCT02320045 ↗

Description as written by the study sponsor.

A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function

Treatments tested

ITCA 650 (Exenatide in osmotic mini pump) Drug

Main thing measured	24-h Area under the Curve at steady state (AUCt,ss)
Sponsor	Intarcia Therapeutics
Conditions studied	Renal Insufficiency
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02320045 ↗