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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01114750
• Date of registration: 29/04/2010
• Prospective Registration: No
• Primary sponsor: Bows Pharmaceuticals AG
• Public title: A Study to Determine the Absorption of Peroral Insulin in Dextran Matrix (ORA3) ORA3
• Scientific title: A Placebo-controlled Study of Insulin Absorption in Healthy Volunteers After Single-dose Oral Administration of Insulin in Dextran Matrix
• Date of first enrolment: April 2010
• Target sample size: 8
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT01114750
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Sweden

Contacts

• Name: Nabil Al-Tawil, M.D.; Ph.D.
• Affiliation: Karolinska Trial Alliance, Stockholm

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Drug: Insulin in dextran matrix capsule (and placebo)

Primary Outcome(s)

Pharmacokinetic variable: insulin [Time Frame: 3-5 hours]

Secondary ID(s)

ORA3-2010-019098-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors