Healthy Adult Male and Female VolunteersPhase 1NCT02650479
Study of the Effects of Intravenous Exenatide on Cardiac Repolarization
A Phase 1 study testing Exenatide, Moxifloxacin and Palonosetron in people with Healthy Adult Male and Female Volunteers, run by Intarcia Therapeutics at 1 site in Netherlands.
Trial summary
Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- Exenatide, Moxifloxacin and Palonosetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Apr 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 35 kg/m2 inclusive.
- 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 spermacide.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), and bilirubin within normal range at Screening.
- Fasting triglycerides within the normal range at Screening
Who cannot join
- History of type 1 or type 2 diabetes, or history of hypoglycemia.
- History or evidence of myocardial infarction, congestive heart failure, syncope not related to heart arrhythmia, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke or TIA.
- History of atrial fibrillation, flutter, or non-sustained or sustained VT.
- Personal or family history of sudden death or long QT syndrome.
- History of uncontrolled hypertension.
- History or evidence of acute or chronic pancreatitis.
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- History of liver disease.
- Abnormal renal function.
- History of medullary thyroid cancer or a personal or family history of multiple endocrine neoplasia type 2.
- Thyroid-stimulating hormone (TSH) outside of normal limits at Screening .
- Weight loss surgery.
- History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years). (Subjects who have been disease free for greater than 5 years may be included.)
- History of active alcohol within 1 year prior to Screening.
- History of drug abuse within 5 years prior to Screening or a positive prestudy drug screen.
- Weekly consumption of more than 14 alcoholic beverages for females and more than 21 alcoholic beverages for males.
- Smoke more than 10 cigarettes per day.
- Excessive in xanthine consumption (more than 5 cups of coffee or equivalent per day).
- History of hypersensitivity to any of the medications used in this study.
- Women that are pregnant, lactating, or planning to become pregnant.
- History of or positive results on screening tests for hepatitis B and/or hepatitis C and/or human immunodeficiency virus (HIV).
- History or evidence of immunocompromised status.
- Prior or current treatment with any GLP-1 receptor agonist (eg, Bydureon™, Byetta®, Victoza®, Tanzeum® or exogenous native GLP-1) or prior participation in an ITCA 650 clinical trial.
- Any gastrointestinal complaints within 7 days prior to first dosing.
- Use of medications within 14 days of first dose other than hormone replacement therapy and oral contraceptives.
- Chronic (8 consecutive days or greater) treatment with systemic corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers
Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers
Read the detailed description
This single-center Phase I study will consist of 2 parts, a Pilot Part and a Core Part.
The Pilot Part of the study will be an open-label, non-randomized, single-treatment design in 10 healthy male and female subjects to determine if an infusion regimen of a 6-h continuous IV infusion of exenatide will lead to a mean plasma steady state concentration of 500 pg/mL.
The Core part of the study will be a double-blind (except for the use of open label active control moxifloxacin), randomized, placebo-controlled,3 period, 6-sequence, cross-over design in 72 healthy male and female subjects to evaluate whether exenatide at therapeutic and supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization (threshold value >10 msec).
- Conditions
- Healthy Adult Male and Female Volunteers
- Being tested
- Exenatide, Placebo, Moxifloxacin, Palonosetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
6 hour IV infusion (double infusion of 0.1250 mcg/kg/hour for 30 min followed by infusion rate (1X) of 0.0625 mcg/kg/hour for 5.5 hours).
PlaceboDrug
6 hour IV infusion.
MoxifloxacinDrug
400 mg oral dose moxifloxacin within 1 min of start of infusion of exenatide
PalonosetronDrug
0.25 mg administered IV within 30 minutes prior to initiating the infusion of exenatide
| Study group | Role | What they receive |
|---|---|---|
| IV exenatide - pilot study | Other | IV Exenatide Infusion 0.1250 mcg/kg/hour for 0.5 hours followed by 0.0625 mcg/kg/hour for 5.5 hours, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. Receives: Drug: Exenatide; Drug: Palonosetron |
| Treatment Group A - core study | Experimental | IV Exenatide Infusion 0.1250 mcg/kg/hour for 0.5 hours followed by 0.0625 mcg/kg/hour for 5.5 hours, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. Receives: Drug: Exenatide; Drug: Palonosetron |
| Treatment Group B - core study | Experimental | IV infusion of placebo over 6 hours, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. Receives: Drug: Placebo; Drug: Palonosetron |
| Treatment Group C - core study | Experimental | IV infusion of placebo over 6 hours and a single oral dose of 400 mg moxifloxacin within 1 min of start of infusion, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. Receives: Drug: Placebo; Drug: Moxifloxacin; Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL
Measured: 35 days
Core Study: Changes to QTc interval changes (threshold > 10 msec) measurements
Measured: 56 days
Secondary outcomes (15)
Pilot Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs
Measured: 35 days
Core Study: Measurement of exenatide plasma concentrations and relationship to changes in QTc interval measurements
Relationship between plasma concentrations of exenatide and QTc interval.
Measured: 56 days
Core Study: Changes in PR, RR, QRS, QT, T- and U- wave morphology
Measured: 56 days
Core Study: Measurement of QTc interval changes moxifloxacin as active control
Measured: 56 days
Core Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs
Measured: 56 days
Pilot Study: Maximum concentration (CMax) of exenatide
Measured: 35 days
Pilot Study: Time to maximum concentration (TMax) of exenatide
Measured: 35 days
Pilot Study: Area under the curve (AUC) of exenatide
Measured: 35 days
Pilot Study: Steady state concentration (Css) of exenatide
Measured: 35 days
Pilot Study: Half life (T1/2) of exenatide
Measured: 35 days
Core Study: Half life (T1/2) of exenatide
Measured: 56 days
Core Study: Steady state concentration (Css) of exenatide
Measured: 56 days
Core Study: Area under the curve (AUC) of exenatide
Measured: 56 days
Core Study: Maximum concentration (CMax)
Measured: 56 days
Core Study: Time to maximum concentration (TMax) of exenatide
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650479
- Sponsor's protocol ID
- ITCA-650-CLP-114
- Status last verified
- Jun 2016
- First submitted
- 1 Jan 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02650479
- Acronym / sponsor ID
- ITCA-650-CLP-114
- Conditions
- Healthy Adult Male and Female Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers
Detailed description
This single-center Phase I study will consist of 2 parts, a Pilot Part and a Core Part.
The Pilot Part of the study will be an open-label, non-randomized, single-treatment design in 10 healthy male and female subjects to determine if an infusion regimen of a 6-h continuous IV infusion of exenatide will lead to a mean plasma steady state concentration of 500 pg/mL.
The Core part of the study will be a double-blind (except for the use of open label active control moxifloxacin), randomized, placebo-controlled,3 period, 6-sequence, cross-over design in 72 healthy male and female subjects to evaluate whether exenatide at therapeutic and supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization (threshold value >10 msec).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IV exenatide - pilot study | Other | Drug: Exenatide, Drug: PalonosetronIV Exenatide Infusion 0.1250 mcg/kg/hour for 0.5 hours followed by 0.0625 mcg/kg/hour for 5.5 hours, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. |
| Treatment Group A - core study | Experimental | Drug: Exenatide, Drug: PalonosetronIV Exenatide Infusion 0.1250 mcg/kg/hour for 0.5 hours followed by 0.0625 mcg/kg/hour for 5.5 hours, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. |
| Treatment Group B - core study | Experimental | Drug: Placebo, Drug: PalonosetronIV infusion of placebo over 6 hours, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. |
| Treatment Group C - core study | Experimental | Drug: Placebo, Drug: Moxifloxacin, Drug: PalonosetronIV infusion of placebo over 6 hours and a single oral dose of 400 mg moxifloxacin within 1 min of start of infusion, preceded by IV Palonosetron 0.25 mg for nausea/vomiting prophylaxis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 19 to 35 kg/m2 inclusive.
- 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 spermacide.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), and bilirubin within normal range at Screening.
- Fasting triglycerides within the normal range at Screening
Key exclusion criteria (25 listed)
- History of type 1 or type 2 diabetes, or history of hypoglycemia.
- History or evidence of myocardial infarction, congestive heart failure, syncope not related to heart arrhythmia, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke or TIA.
- History of atrial fibrillation, flutter, or non-sustained or sustained VT.
- Personal or family history of sudden death or long QT syndrome.
- History of uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide6 hour IV infusion (double infusion of 0.1250 mcg/kg/hour for 30 min followed by infusion rate (1X) of 0.0625 mcg/kg/hour for 5.5 hours). | Drug | IV exenatide - pilot study, Treatment Group A - core study |
| Placebo6 hour IV infusion. | Drug | Treatment Group B - core study, Treatment Group C - core study |
| Moxifloxacin400 mg oral dose moxifloxacin within 1 min of start of infusion of exenatide | Drug | Treatment Group C - core study |
| Palonosetron0.25 mg administered IV within 30 minutes prior to initiating the infusion of exenatide | Drug | IV exenatide - pilot study, Treatment Group A - core study, Treatment Group B - core study, Treatment Group C - core study |
Primary outcome
Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL
Time frame: 35 days
Core Study: Changes to QTc interval changes (threshold > 10 msec) measurements
Time frame: 56 days
15 secondary outcomes
Pilot Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs
Time frame: 35 days
Core Study: Measurement of exenatide plasma concentrations and relationship to changes in QTc interval measurements
Time frame: 56 days
Core Study: Changes in PR, RR, QRS, QT, T- and U- wave morphology
Time frame: 56 days
Core Study: Measurement of QTc interval changes moxifloxacin as active control
Time frame: 56 days
Core Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs
Time frame: 56 days
Pilot Study: Maximum concentration (CMax) of exenatide
Time frame: 35 days
Pilot Study: Time to maximum concentration (TMax) of exenatide
Time frame: 35 days
Pilot Study: Area under the curve (AUC) of exenatide
Time frame: 35 days
Pilot Study: Steady state concentration (Css) of exenatide
Time frame: 35 days
Pilot Study: Half life (T1/2) of exenatide
Time frame: 35 days
Core Study: Half life (T1/2) of exenatide
Time frame: 56 days
Core Study: Steady state concentration (Css) of exenatide
Time frame: 56 days
Core Study: Area under the curve (AUC) of exenatide
Time frame: 56 days
Core Study: Maximum concentration (CMax)
Time frame: 56 days
Core Study: Time to maximum concentration (TMax) of exenatide
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exenatide, Moxifloxacin and Palonosetron in people with Healthy Adult Male and Female Volunteers, run by Intarcia Therapeutics at 1 site in Netherlands.
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 25 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 Netherlands. 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?
Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL (time frame: 35 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.