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

Diabetes Mellitus Clinical Trial

— ORA3  

Official title:

A Placebo-controlled Study of Insulin Absorption in Healthy Volunteers After Single-dose Oral Administration of Insulin in Dextran Matrix

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01114750
• Other study ID #: ORA3-2010-019098-14
• Status: Suspended
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: October 3, 2010
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Bows Pharmaceuticals AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 8
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin in dextran matrix capsule (and placebo)
Single dose capsule (and placebo)

Locations

Country	Name	City	State
Sweden	Karolinska Trial Alliance (KTA), Phase I Unit	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Bows Pharmaceuticals AG

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic variable: insulin	Estimation of insulin AUC and Cmax post dose-administration	3-5 hours	No