- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641899
Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs
January 26, 2017 updated by: Intarcia Therapeutics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Acetaminophen will be use to assess the effect of ITCA 650 on the rate of gastric emptying.
Interactions between ITCA 650 and the medications lisinopril, digoxin, atorvastatin, and warfarin will also be studied.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Quintiles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Contraindications or warnings according to the specific label(s) for acetaminophen, atorvastatin, lisinopril, digoxin or warfarin therapy.
- Women that are pregnant, lactating, or planning to become pregnant.
- Concurrent use of anticoagulants, including daily low dose aspirin (81 mg).
- History of or positive results on screening tests for hepatitis B and/or hepatitis C and/or human immunodeficiency virus (HIV).
- Planned in-patient surgery, dental procedure, or hospitalization during the study.
- Prior or current treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (eg, Bydureon™, Byetta®, Victoza®, Tanzeum® or exogenous native GLP-1) or prior participation in an ITCA 650 clinical trial.
- Use or intended use of any drug or other product that inhibits or induces cytochrome P450 (CYP)1A2, CYP2C9, CYP2C19, or CYP3A4 within 14 days prior to the first dose of warfarin or ITCA650 or during the conduct of the study.
- History of thrombophlebitis, thromboembolic disorders, or deep vein thrombophlebitis.
- Fasting triglycerides above upper limit of normal at Screening.
- Any gastrointestinal complaints within 7 days prior to first dosing.
- Taking drugs or natural herbal supplements (such as albuterol, antacids, and St. John's Wort) with known interactions with atorvastatin, lisinopril, digoxin, or warfarin from within 7 days prior to Day 1 until EOS
- Consumed or unwilling to refrain from grapefruit, cranberries, grapefruit- or cranberry-containing products, or Seville oranges from within 7 days prior to Day 1 until EOS.
- Chronic use of analgesics, pain medication, or non-steroidal anti-inflammatory agents.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Treatment
ITCA 650 20/60 mcg/day Acetaminophen 1000 mg Atorvastatin 40 mg Lisinopril 20 mg Warfarin 25 mg Digoxin 0.5 mg
|
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.
Oral acetaminophen 1000 mg on Day 1 and Day 27
Oral atorvastatin 40 mg on Day 2 and Day 28
Oral lisinopril 20 mg on Day 2 and Day 28
Oral warfarin 25 mg on Day 2 and Day 28
Oral digoxin 0.5 mg on Day 2 and Day 28
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Maximum plasma concentration ([Cmax]) of acetaminophen alone and in the presence of ITCA 650
Time Frame: time zero to 10 weeks
|
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 Frame: time zero to 10 weeks
|
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 Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to maximum plasma concentration (tmax) of acetaminophen
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
tmax of atorvastatin, lisinopril, digoxin, R warfarin, and S-warfarin
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
AUC(0-last) of orthohydroxy-atorvastatin and parahydroxy-atorvastatin
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Cmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin
Time Frame: time zero to 10 weeks
|
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 Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Cmax of ITCA 650, 20 mcg/d and 60 mcg/d
Time Frame: within 8 hours after placement of ITCA 650
|
within 8 hours after placement of ITCA 650
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Treatment-emergent adverse events (TEAEs) including any events local to the placement site, clinical laboratory measurements, ECGs, vital signs and physical examinations.
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Tmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Cmin of ITCA 650, 20 mcg/d and 60 mcg/d
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Tmax of ITCA 650, 20 mcg/d and 60 mcg/d
Time Frame: time zero to 10 weeks
|
time zero to 10 weeks
|
Tmin of ITCA 650, 20 mcg/d and 60 mcg/d
Time Frame: zero to 10 weeks
|
zero to 10 weeks
|
Time of maximum effect (tEmax)from time zero to the last measurable concentration (AUEC(0-last)) of international normalized ratio (INR) of warfarin.
Time Frame: zero to 10 weeks
|
zero to 10 weeks
|
Area under the effect-time curve from time zero to the last measurable concentration (AUEC(0-last)) of international normalized ratio (INR) of warfarin.
Time Frame: zero to 10 weeks
|
zero to 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 21, 2015
First Submitted That Met QC Criteria
December 24, 2015
First Posted (Estimate)
December 30, 2015
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
January 26, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Antimetabolites
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Protective Agents
- Cardiotonic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Anticoagulants
- Anti-Obesity Agents
- Incretins
- Angiotensin-Converting Enzyme Inhibitors
- Digoxin
- Atorvastatin
- Acetaminophen
- Warfarin
- Exenatide
- Lisinopril
Other Study ID Numbers
- ITCA 650-CLP-115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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