A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01149694
• Date of registration: 22/06/2010
• Prospective Registration: No
• Primary sponsor: PurGenesis Technologies Inc.
• Public title: A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
• Scientific title: A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers
• Date of first enrolment: June 2009
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01149694
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Theophilus J Gana, MD, PhD
• Affiliation: PurGenesis Technologies Inc.

• Name: Sergej Berger, MD
• Affiliation: FOCUS Clinical Drug Development GmbH

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult non-smoking male volunteers between the ages of 18 to 55 years,
inclusive.

- Must provide a voluntary written informed consent prior to initiation of screening,
must be capable of following the verbal and written study instructions, and be able
to commit to any confinements and return visits during the entire period of the
study.

- Must have a body mass index (BMI) that is within 18 to 30 kg/m2 on the BMI Chart.

- Must have a normal digital rectal examination at screening.

- Must have normal colonic and rectal mucosa at the baseline flexible sigmoidoscopy
(i.e., no bleeding, inflammation, edema, ulceration or other abnormal finding).

- Must have no clinically significant abnormal findings in their medical history,
physical examination or clinical laboratory test results.

Exclusion Criteria:

- History or presence of clinically significant cardiovascular, pulmonary, hepatic,
renal, hematological, gastrointestinal, endocrine, immunologic, dermatological,
neurological, or psychiatric disease.

- History of allergic reaction or hypersensitivity to spinach, spinach tablet, spinach
powder or spinach extract; and to latex, molds and mushrooms.

- Subjects with abnormal digital rectal examination at screening

- Subjects with abnormal colonic and rectal mucosa at the baseline flexible
sigmoidoscopy i.e., have bleeding, inflammation, edema or ulceration or other
abnormal finding.

- Subjects who used NSAIDs within 14 days prior to dosing.

- History of pseudoallergic hypersensitivity to the food color additives, tartrazine
(E102) and sunset yellow (E110), allergic asthma, aspirin intolerance, and severe or
multiple allergies.

- History of gout, pseudogout or hyperuricemia.

- History of kidney stones.

- Past medical history of significant colonic surgery, except for benign polyp removal.

- Subjects with anatomical abnormalities of the colon, e.g., short bowel or other
abnormalities.

- Subjects with a history of rectal bleeding, passage of mucus rectally, and irregular
bowel habits, e.g., frequent diarrhea or constipation.

- Subjects with internal or external hemorrhoids.

- History or presence of alcoholism or drug abuse within the past 2 years.

- Subjects with a current history of smoking. If a former smoker, must have stopped
smoking for at least 3 months to qualify for study entry.

- Subjects who tested positive at screening for HIV, HbsAg or HCV.

- Subjects who used any prescription medications within 14 days prior to dosing.

- Subjects who used any rectal enema or laxative within 7 days prior to dosing.

- Subjects who used any over-the-counter (OTC) medications within 7 days prior to
dosing.

- Subjects who have made a donation of blood or blood products (with the exception of
plasma as noted below) within 56 days prior to dosing.

- Subjects who have made a plasma donation within 7 days prior to dosing.

- Subjects with hemoglobin less than 14.0 g/dl.

- Subjects who participated in another clinical trial within 28 days prior to dosing.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: PUR 0110 Rectal Enema or Placebo Enema

Primary Outcome(s)

Incidence, nature and severity of adverse events and abnormal clinical laboratory test results [Time Frame: After single-ascending doses]

Secondary Outcome(s)

Maximum tolerated dose (MTD) [Time Frame: After single-ascending doses]

Pharmacokinetic profile and parameters - if specific pharmacokinetic markers are successfully identified [Time Frame: After single-ascending doses]

Secondary ID(s)

2009-010405-36

PG08-PUR 0210-FIM001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors