GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-32•HbA1c ≤6.5%•eGFR ≥80

Primary endpoints

•AUC•Cmax ([Cmax]) of acetaminophen alone and in the presence of ITCA 650•AUC of atorvastatin, lisinopril, digoxin, R-warfarin

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02641899

Org study IDITCA 650-CLP-115

Timeline

Milestones

Study first posted2015-12-30estimated

Last update posted2017-01-27estimated

Study start2015-12 (month precision)

Primary completion2016-03actual (month precision)

Study completion2016-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

15 endpoints

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

Maximum plasma concentration ([Cmax]) of acetaminophen alone and in the presence of ITCA 650

Time frame:time zero to 10 weeks

Cmax

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma concentration (tmax) of acetaminophen

Time frame:time zero to 10 weeks

Tmax

descriptive

Secondary/protocol endpoint

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

Time frame:time zero to 10 weeks

Tmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:time zero to 10 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin

Time frame:time zero to 10 weeks

Cmax

concentration, descriptive

Secondary/protocol endpoint

Cmax of ITCA 650, 20 mcg/d and 60 mcg/d

Time frame:within 8 hours after placement of ITCA 650

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Tmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin

Time frame:time zero to 10 weeks

Tmax

descriptive

Secondary/protocol endpoint

Cmin of ITCA 650, 20 mcg/d and 60 mcg/d

Time frame:time zero to 10 weeks

concentration, descriptive

Secondary/protocol endpoint

Tmax of ITCA 650, 20 mcg/d and 60 mcg/d

Time frame:time zero to 10 weeks

Tmax

concentration, descriptive

Secondary/protocol endpoint/low confidence

Tmin of ITCA 650, 20 mcg/d and 60 mcg/d

Time frame:zero to 10 weeks

Tmax

descriptive

Secondary/protocol endpoint/low confidence

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

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.