AzTrials
AzTrials

HealthyEarly Phase 1IAM-POCNCT02304211

Intra-Arterial Microdosing: Proof-of-Concept in Humans

A Early Phase 1 study testing Insulin in people with Healthy, run by Duke University 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
Search all trials

Trial summary

The purpose of this protocol is to demonstrate that intra-arterial administration of a drug can generate information in a manner that faithfully mimics effects of systemic administration but with little or no systemic effects. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Dec 2014to Jul 2015
Phase
Early 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 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Healthy, non-smoking male subjects, 18 - 40 years of age with a BMI of 18 - 32 kg/m2 [BMI is rounded to the nearest tenth - a BMI of 32.045 should be rounded up to 32.05, which also would be rounded up to 32.1 and subject would be excluded; a BMI of 32.044 should be rounded down to 32.04 which would also be rounded down to 32.0 and the subject would be included].
  • Subject's health status will be determined by the medical history, physical examination, vital signs, electrocardiogram, blood chemistry, hematology, and urinalysis performed at screening.
  • Subjects must be willing to fast a minimum of 8 hours.
  • Subjects must be willing to abstain from alcohol from 2 days prior to Day 1 of the study until discharge.
  • Subjects must be willing to remain in the clinical research unit for the inpatient portion of the study from admission to discharge on Day 1.
Show all 9Show fewer
  • Subjects must agree not to donate blood, plasma, platelets, or any other blood components during the study and for 4 weeks after completion of the study.
  • Renal function (creatinine clearance [CLcr] > 80 mL/min as calculated using the Cockcroft-Gault equation using lean body weight [LBW]) (Cockcroft and Gault 1976)
  • Subjects must have adequate arterial and venous access for receiving intra-arterial insulin infusions and placement of intravenous catheters for the collection of biomarker samples; and a positive Allen Test.

Who cannot join

  • Subjects with laboratory results outside the normal range, if considered clinically significant by the Investigator.
  • Hemoglobin concentration < 12.0 g/dL.
  • A mental capacity that is limited to the extent that the subject cannot provide legal consent or understand information regarding the potential risks of the study procedures and potential side effects of the investigational product.
  • Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years.
  • Unwillingness or lack of ability to comply with the protocol or cooperate fully with the Principal Investigator and site personnel.
  • Use of any of the following:
Show all 30Show fewer
  • Any concomitant medication. Subjects who have received any prescribed or non-prescribed (over-the-counter [OTC]) systemic, topical, or oral medications, herbal or vitamin supplements within 14 days from Day 1. St. John's Wort (hypericin) must not have been taken for at least 30 days prior Day 1.
  • Any drugs, foods or substances known to interfere with the acute effects of insulin or the biomarkers being evaluated within 14 days prior to Day 1.
  • Caffeine-or xanthine-containing products for 24 hours prior to Day 1 until discharged.
  • Use of alcohol for 48 hours prior to Day 1 until discharged.
  • Clinically significant ECG abnormality in the opinion of the Investigator.
  • Vital signs or clinically significant laboratory values at the screening visit that in the opinion of the Investigator would make the subject an inappropriate candidate for the study.
  • Has taken any investigational drug during the previous 30 days (or 5 half-lives, whichever is longer) prior to the screening visit or is currently participating in another investigational clinical trial.
  • Made any significant (as assessed by the investigator) donation (including plasma) or have had a significant loss of blood within 90 days prior to Day 1.
  • History or manifestation of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, pulmonary, metabolic, endocrine, hematologic or other medical disorders.
  • Serious mental or physical illness within the past year.
  • History of regular alcohol consumption within 6 months of the study defined as:
  • An average weekly intake of >14 drinks. One drink is equivalent to 12 g of alcohol: 12 ounces (360mL) of beer, 5 ounces (150mL) of wine or 1.5 ounces (45mL) of 80 proof distilled spirits.
  • Failure to agree to abstain from alcohol from 2 days before dosing.
  • Positive results on tests for drugs of abuse, cotinine or alcohol (breathalyzer) at screening or the assessment at check-in on Day 1.
  • Subjects who have used tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within 6 months prior consenting.
  • History of sensitivity to insulin, 18F-FDG or other drugs (lidocaine) or other significant allergy that, in the opinion of the physician, contraindicates participation. This includes sensitivity to heparin or heparin-induced thrombocytopenia, if heparin is be used to maintain catheter patency.
  • Subjects who, in the opinion of the Investigator, should not participate in the study.
  • Subjects who are employed by the DCRU
  • Subjects who have a history of unexplained syncope; i.e., autonomic dysfunction (vasovagal syncope) or from blood collections.
  • Subjects who have a history of symptomatic hypotension and symptomatic hypoglycemia from fasting.
  • Lack of ability to understand verbal and/ or written English
  • History of clinically significant illness within 4 weeks prior to Day 1
  • Receipt of a transfusion or any blood products within 90 days prior to Screening.
  • Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

The purpose of this protocol is to demonstrate that intra-arterial administration of a drug can generate information in a manner that faithfully mimics effects of systemic administration but with little or no systemic effects.

Read the detailed description

IAM is a novel approach combining the methodologies and techniques of 'microdosing' and 'intra-arterial drug delivery' to test new drugs in targeted organs or tissues. The main feature of this approach is that when a microdose (defined as 1/100th of the total body minimal pharmacological dose) is given into a body area 1/100th of the total body mass - a temporary pharmacological concentration is generated in that area that may be sufficient to generate and detect a biomarker relevant to the drug's safety and efficacy. The drug then returns systemically and is diluted to become a subpharmacological microdose. The significance of the approach is in the ability to obtain information on novel drugs in humans in a safe manner.

Insulin will be administered into the radial artery and compared with systemic administration. The effects on the ipsilateral hand will be compared with systemic effects and effects on the contralateral hand. The outcomes will be insulin pharmacokinetics, glucose and potassium levels, and 18F fluorodeoxyglucose (FDG) uptake as measured with Positron Emission Tomography (PET) imaging.

Conditions
Healthy
Being tested
Insulin
Keywords
Microdosing, Phase 0, Exploratory Investigational New Drug (IND), Intra-Arterial, PET Imaging

What participants receive

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

  • InsulinDrug

    Insulin will be administered either into the radial artery (microdose intervention) or IV (systemic intervention).

Study groups in NCT02304211
Study groupRoleWhat they receive
Intra-Arterial Microdose InsulinExperimentalHealthy volunteers will receive microdose insulin intra-arterially into the radial artery.
Receives: Drug: Insulin
Systemic InsulinActive comparatorHealthy volunteers will receive full-dose insulin intra-venously.
Receives: Drug: Insulin

What is being measured

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

  1. Glucose Plasma Levels

    Measured: 2 hours

  2. 18F-FDG Uptake as measured with Positron Emission Tomography (PET) imaging

    Measured: 2 hours

Secondary outcomes (2)

  1. Potassium Plasma Levels

    Measured: 2 hours

  2. Lactic Acid Plasma Levels

    Measured: 2 hours

Timeline

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

  1. First posted1 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304211
Sponsor's protocol ID
Pro00056933
Acronym
IAM-POC
Status last verified
Aug 2016
First submitted
26 Nov 2014
Last updated
23 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: PET Imaging data presently being analyzed for presentation and final manuscript publication

Publications

  • Burt T, Rouse DC, Lee K, Wu H, Layton AT, Hawk TC, Weitzel DH, Chin BB, Cohen-Wolkowiez M, Chow SC, Noveck RJ. Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats. J Nucl Med. 2015 Nov;56(11):1793-9. doi: 10.2967/jnumed.115.160986. Epub 2015 Aug 27.

    PubMed 26315828

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Insulin in people with Healthy, run by Duke University 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 9 inclusion and 30 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 23 Dec 2016. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Glucose Plasma Levels (time frame: 2 hours). 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?

On the ClinicalTrials.gov record for NCT02304211, which also lists 1 linked publication.

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 23 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in