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HealthyPhase 1NCT02641899

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

A Phase 1 study testing ITCA 650 20/60 mcg/day, Acetaminophen and Atorvastatin in people with Healthy, run by Intarcia Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ITCA 650 20/60 mcg/day, Acetaminophen and Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Dec 2015to Mar 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Quintiles

    Overland Park, Kansas, 66211

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Healthy
Being tested
ITCA 650 20/60 mcg/day, Acetaminophen, Atorvastatin, Lisinopril, Warfarin
Keywords
Adult, Male, Female, Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ITCA 650 20/60 mcg/dayDrug

    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.

  • AcetaminophenDrug

    Oral acetaminophen 1000 mg on Day 1 and Day 27

  • AtorvastatinDrug

    Oral atorvastatin 40 mg on Day 2 and Day 28

  • LisinoprilDrug

    Oral lisinopril 20 mg on Day 2 and Day 28

  • WarfarinDrug

    Oral warfarin 25 mg on Day 2 and Day 28

  • DigoxinDrug

    Oral digoxin 0.5 mg on Day 2 and Day 28

Study groups in NCT02641899
Study groupRoleWhat they receive
Experimental TreatmentExperimentalITCA 650 20/60 mcg/day Acetaminophen 1000 mg Atorvastatin 40 mg Lisinopril 20 mg Warfarin 25 mg Digoxin 0.5 mg
Receives: Drug: ITCA 650 20/60 mcg/day; Drug: Acetaminophen; Drug: Atorvastatin; Drug: Lisinopril; Drug: Warfarin; Drug: Digoxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: time zero to 10 weeks

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

    Measured: 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.

    Measured: 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.

    Measured: time zero to 10 weeks

Secondary outcomes (13)

  1. Time to maximum plasma concentration (tmax) of acetaminophen

    Measured: time zero to 10 weeks

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

    Measured: time zero to 10 weeks

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

    Measured: time zero to 10 weeks

  4. Cmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin

    Measured: 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.

    Measured: time zero to 10 weeks

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

    Measured: 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.

    Measured: time zero to 10 weeks

  8. Tmax of orthohydroxy-atorvastatin and parahydroxy-atorvastatin

    Measured: time zero to 10 weeks

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

    Measured: time zero to 10 weeks

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

    Measured: time zero to 10 weeks

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

    Measured: 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.

    Measured: 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.

    Measured: zero to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641899
Sponsor's protocol ID
ITCA 650-CLP-115
Status last verified
Jan 2017
First submitted
21 Dec 2015
Last updated
27 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ITCA 650 20/60 mcg/day, Acetaminophen and Atorvastatin in people with Healthy, run by Intarcia Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641899.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.

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