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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641899
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ITCA 650 20/60 mcg/day Drug: Acetaminophen Drug: Atorvastatin Drug: Lisinopril Drug: Warfarin Drug: Digoxin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

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
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




Primary Outcome Measures :
  1. 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 ]
  2. Maximum plasma concentration ([Cmax]) of acetaminophen alone and in the presence of ITCA 650 [ Time Frame: time zero to 10 weeks ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Time to maximum plasma concentration (tmax) of acetaminophen [ Time Frame: time zero to 10 weeks ]
  2. tmax of atorvastatin, lisinopril, digoxin, R warfarin, and S-warfarin [ Time Frame: time zero to 10 weeks ]
  3. AUC(0-last) of orthohydroxy-atorvastatin and parahydroxy-atorvastatin [ Time Frame: time zero to 10 weeks ]
  4. Cmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin [ Time Frame: time zero to 10 weeks ]
  5. 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 ]
  6. Cmax of ITCA 650, 20 mcg/d and 60 mcg/d [ Time Frame: within 8 hours after placement of ITCA 650 ]
  7. 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 ]
  8. Tmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin [ Time Frame: time zero to 10 weeks ]
  9. Cmin of ITCA 650, 20 mcg/d and 60 mcg/d [ Time Frame: time zero to 10 weeks ]
  10. Tmax of ITCA 650, 20 mcg/d and 60 mcg/d [ Time Frame: time zero to 10 weeks ]
  11. Tmin of ITCA 650, 20 mcg/d and 60 mcg/d [ Time Frame: zero to 10 weeks ]
  12. 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 ]
  13. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641899


Locations
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United States, Kansas
Quintiles
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Intarcia Therapeutics

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Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT02641899    
Other Study ID Numbers: ITCA 650-CLP-115
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intarcia Therapeutics:
Adult
Male
Female
Volunteers
Additional relevant MeSH terms:
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Acetaminophen
Exenatide
Digoxin
Lisinopril
Warfarin
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anticoagulants
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Hypoglycemic Agents
Anti-Obesity Agents
Incretins
Hormones