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

NCT02641899 | Completed Phase 1

• 1 other identifier: ITCA 650-CLP-115
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adult; Male; Female; Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (13)

• Time to maximum plasma concentration (tmax) of acetaminophen

  time zero to 10 weeks

• tmax of atorvastatin, lisinopril, digoxin, R warfarin, and S-warfarin

  time zero to 10 weeks

• AUC(0-last) of orthohydroxy-atorvastatin and parahydroxy-atorvastatin

  time zero to 10 weeks

• Cmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin

  time zero to 10 weeks

• Maximum effect (Emax)from time zero to the last measurable concentration (AUEC(0-last)) of international normalized ratio (INR) of warfarin.

  time zero to 10 weeks

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

ITCA 650 20/60 mcg/day Acetaminophen 1000 mg Atorvastatin 40 mg Lisinopril 20 mg Warfarin 25 mg Digoxin 0.5 mg

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

Interventions

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.

Experimental Treatment

Acetaminophen DRUG

Oral acetaminophen 1000 mg on Day 1 and Day 27

Experimental Treatment

Atorvastatin DRUG

Oral atorvastatin 40 mg on Day 2 and Day 28

Experimental Treatment

Lisinopril DRUG

Oral lisinopril 20 mg on Day 2 and Day 28

Experimental Treatment

Warfarin DRUG

Oral warfarin 25 mg on Day 2 and Day 28

Experimental Treatment

Digoxin DRUG

Oral digoxin 0.5 mg on Day 2 and Day 28

Experimental Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) between 19 to 32 kg/m2.
• Glycosylated hemoglobin A1c (HbA1c )\<6.5%.
• Normal renal function (eGFR ≥80 mL/min/1.73 m2).
• Women of child bearing potential - use of an additional adequate method of contraception during the study and until 1 additional menstrual cycle following the end-of-study (EOS) visit. Adequate methods of contraception for women of child bearing potential (WOCBP) include: mechanical products (ie, intrauterine device \[IUD\]-copper IUD); or barrier methods (eg, diaphragm, condoms, cervical cap) with spermicide.

You may not qualify if:

• History of type 1 or type 2 diabetes.
• History or evidence of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
• History of uncontrolled hypertension.
• History or evidence of acute or chronic pancreatitis.
• History of liver disease.
• History of medullary thyroid cancer or a personal or family history of multiple endocrine neoplasia type 2.
• Poor thyroid, liver, or renal function.
• Weight loss surgery or requires weight loss medications.
• History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years). (Subjects who have been disease free for 5 years may be included.)
• History of active alcohol or substance abuse.
• Weekly consumption of more than 7 alcoholic beverages for females and 14 alcoholic beverages for males.
• Excessive in xanthine consumption (more than 5 cups of coffee or equivalent per day).
• Treatment with medications that affect GI motility.
• Any condition that would affect drug transit time or absorption (eg, gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, chronic diarrhea, vagotomy, chronic gastroesophageal reflux disease, malabsorption, colostomy, Crohn's disease, ulcerative colitis, or celiac sprue).
• History of hypersensitivity to exenatide.

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

Exenatide; Acetaminophen; Atorvastatin; Lisinopril; Warfarin; Digoxin

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dipeptides; Oligopeptides; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)