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

Registration

Registration

NCT02641899

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

33

Start

2015-12

Primary completion

2016-03

Lead sponsor

Intarcia Therapeutics

Conditions

Healthy

Interventions

DRUG:ITCA 650 20/60 mcg/day; DRUG:Acetaminophen; DRUG:Atorvastatin; DRUG:Lisinopril; DRUG:Warfarin; DRUG:Digoxin

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• 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 zero to 10 weeks]
• Maximum plasma concentration ([Cmax]) of acetaminophen alone and in the presence of ITCA 650 [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 zero to 10 weeks]
• Cmax of atorvastatin, lisinopril, digoxin, R-warfarin, and S-warfarin each alone and in the presence of ITCA 650. [time zero to 10 weeks]