A Study to Determine the Absorption of Peroral Insulin in Dextran Matrix (ORA3)

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Bows Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT01114750
First received: April 29, 2010
Last updated: October 3, 2010
Last verified: October 2010
  Purpose

A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix after single dose administration.


Condition Intervention Phase
Diabetes Mellitus
Drug: Insulin in dextran matrix capsule (and placebo)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Placebo-controlled Study of Insulin Absorption in Healthy Volunteers After Single-dose Oral Administration of Insulin in Dextran Matrix

Resource links provided by NLM:


Further study details as provided by Bows Pharmaceuticals AG:

Primary Outcome Measures:
  • Pharmacokinetic variable: insulin [ Time Frame: 3-5 hours ] [ Designated as safety issue: No ]
    Estimation of insulin AUC and Cmax post dose-administration


Estimated Enrollment: 8
Study Start Date: April 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Insulin in Dextran Matrix
A group consisting of male healthy volunteers will be given placebo and one single dose of insulin in dextran matrix, for estimation of post-dose relative bioavailability.
Drug: Insulin in dextran matrix capsule (and placebo)
Single dose capsule (and placebo)
Placebo Comparator: Placebo
A group consisting of male healthy volunteers will be given placebo and one single dose of insulin in dextran matrix, for estimation of post-dose relative bioavailability.
Drug: Insulin in dextran matrix capsule (and placebo)
Single dose capsule (and placebo)

Detailed Description:

The study is a single blind, cross over study where each subject will receive a a single active dose (200 IU) of insulin in dextran matrix and placebo on two different experimental days.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects, age 18-40 years.
  • Fasting blood glucose within the range 4.0-6.0 mmol/L at Screening, and on Day 1 before dosing ≥ 4 mmol/L. However, the subject should not be excluded from the study if the blood glucose is out of this range once the treatment period has started.
  • Body Mass Index (BMI) of 20-27 kg/m2
  • Medically stable as determined by history and physical examination, including vital signs.
  • Screening laboratory tests must be within normal range or judged as not clinically significant by Principal investigator/Subinvestigator.
  • Negative urine ketoacidosis test
  • ECG including QTcB shows no clinically significant abnormality or acute ischemia
  • Supine BP ≤ 139/89 mm Hg diastolic/systolic, or at the discretion of the investigator
  • Able to adhere to the study visit schedule, and to understand and comply with other protocol requirements.
  • Capable of giving informed consent, which must be obtained prior to any screening procedures.
  • Negative laboratory screen for Hepatitis B (HBsAg and anti-HBc antibodies), Hepatitis C (anti HCV) and HIV (1&2).
  • Willing to refrain from consuming alcohol 48 hours prior to dosing and throughout the period of sample collection.
  • Not on any prohibited medication (See section 8.9), or at the discretion of the investigator.

Exclusion Criteria:

  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or any other condition which increases risk of participation in this trial in the opinion of the investigator.
  • Currently known malignancy or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised more than one year ago with no evidence of recurrence
  • A chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), open skin wound, or ulcer.
  • Other medical conditions, drug treatments or significant medical problems that would preclude participation in a clinical trial that, in the opinion of the investigator, disqualifies the subject.
  • Participation in a clinical trial within the prior 3 months
  • History of GI surgery (other than appendectomy) or known GI motility disorders.
  • History of a serious infection, including but not limited to hepatitis, pneumonia, or pyelonephritis, or have been hospitalized or received intravenous antibiotics for an infection, during the previous two months.
  • A recent adult history of clinically significant allergic reaction to any drug.
  • History of polyps in the gastrointestinal tract.
  • Known to have had a substance abuse (drug or alcohol) problem within the previous 5 years
  • Alcohol use within 48 hours prior to visits to the study unit.
  • Unable to undergo venipunctures for study purposes because of poor tolerability or lack of easy access.
  • Engaging in any strenuous exercise (such as running or weight lifting or playing any team sports such as soccer) within 48 hours prior to visits to the study unit.
  • Donation of plasma within 7 days prior to the first dose.
  • Donation of blood within 3 months prior to the first dose
  • Difficulty in swallowing capsules.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114750

Locations
Sweden
Karolinska Trial Alliance (KTA), Phase I Unit
Stockholm, Sweden
Sponsors and Collaborators
Bows Pharmaceuticals AG
Investigators
Principal Investigator: Nabil Al-Tawil, M.D.; Ph.D. Karolinska Trial Alliance, Stockholm
  More Information

No publications provided

Responsible Party: Nabil Al-Tawil, Karolinska Trial Alliance
ClinicalTrials.gov Identifier: NCT01114750     History of Changes
Other Study ID Numbers: ORA3-2010-019098-14
Study First Received: April 29, 2010
Last Updated: October 3, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Bows Pharmaceuticals AG:
blood glucose
blood insulin
dextran
diabetes
hyperglycemia
hypoglycemia
oral delivery
portal delivery

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Dextrans
Insulin
Insulin, Globin Zinc
Anticoagulants
Blood Substitutes
Hematologic Agents
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014