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

NCT02641899 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-01-27

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641899 on ClinicalTrials.gov