A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle

NCT00602914 | Completed Early Phase 1

• 1 other identifier: NP-1-001
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.

Conditions

Intradermal Injections

Keywords

MicronJet (microneedles); Intradermal

Outcome Measures

Primary Outcomes (1)

• Blood samples for PK and PD will be collected

  pre dose and up to 360 minutes post dose of administration

Secondary Outcomes (1)

• Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires

  All study duration

Study Arms (2)

1

EXPERIMENTAL

10 healthy volunteers will receive 0.1 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order

Device: MicronJet

2

EXPERIMENTAL

10 Type II DM subject will receive 0.2 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order

Device: MicronJet

Interventions

MicronJet DEVICE

The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ranging in age from 18-40 years.
• In good general health as determined by medical history, physical examination, ECG and clinical laboratory tests obtained with 14 days prior to the start of the study.
• BMI\<30 or the volunteer is not considered obese by the Principal Investigator with a written statement at screening.
• Willing and able to abide by the dietary requirements of the study.
• Willing and able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee.

You may not qualify if:

• History of known or suspected clinically significant hypersensitivity to any drug.
• History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• Clinically significant cardiovascular, hepatic, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, coagulation or neoplastic disorders.
• Participation in radiologic studies involving parenteral administration of iodinated contrast materials within two weeks prior to screening.
• Subjects with history of recent alcohol abuse (defined as consumption of more than 21- ml of alcohol per week; or the equivalent of fourteen 4-oz glasses of wine, fourteen 12 oz can/bottle of beer or wine cooler) or other substance abuse.
• Any protocol-required laboratory test abnormality that is considered clinically significant.
• Participation in another investigational drug study within 90 days before the first day of dosing.
• History of non-compliance to medical regimens, or subjects who are considered potentially unreliable.
• Blood or plasma donation within the past 90 days.
• Mentally unstable or incompetent.
• Positive hepatitis C screen or positive hepatitis B screen.
• HIV positive
• B. Type 2 diabetic patients
• Type 2 male patients and post-menopausal females aged 30-70 years.
• HA1c 6.5-10%

Sponsors & Collaborators

• NanoPass Technologies Ltd: lead

Study Officials

• Itamar Raz, MD

  Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2007
• First Posted: January 28, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2009
• Last Updated: May 10, 2013

Record last verified: 2008-04