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

NCT01149694 | Completed Phase 1

• 2 other identifiers: PG08-PUR 0210-FIM0012009-010405-36
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-man study of a novel investigational botanical drug complex, PUR 0110 rectal enema, that has been shown to have potent anti-inflammatory, antioxidant and immunomodulatory effects following in vitro and in vivo pharmacology studies, to assess the safety and tolerability of sequential single-ascending doses in normal healthy volunteers and to determine the maximum tolerated dose (MTD). As a tertiary objective, the study will also investigate the presence of specific pharmacokinetic markers following the administration of single-dose PUR 0110 at each dose level. The study is designed as a single-center, randomized, double-blind, parallel-group, sequential single-ascending dose, placebo-controlled safety, tolerability and pharmacokinetic study of PUR 0110 rectal enema in 24 normal healthy male volunteers. Eligible subjects will be randomly assigned to 4 Cohorts of 6 subjects each to receive active drug (PUR 0110 Enema) or placebo enema as follows: 187.5 mg/60 g - Cohort 1, 375 mg/60 g - Cohort 2, 750 mg/60 g - Cohort 3 or 1500 mg/60 g - Cohort 4. Within each Cohort, subjects will be randomized in a 2:1 ratio to receive either active treatment (PUR 0110 enema; n = 4) or placebo enema (n = 2). Each subject will receive only 1 dose of assigned study medication and dosing of subjects within each cohort will also be by sequential inclusion.

Conditions

Ulcerative Colitis

Keywords

PurGenesis Technologies Inc.; PUR 0110 rectal enema; Ulcerative colitis; Distal; Normal healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence, nature and severity of adverse events and abnormal clinical laboratory test results

  After single-ascending doses

Secondary Outcomes (2)

• Maximum tolerated dose (MTD)

  After single-ascending doses

• Pharmacokinetic profile and parameters - if specific pharmacokinetic markers are successfully identified

  After single-ascending doses

Study Arms (4)

Cohort 1

OTHER

Drug: PUR 0110 Rectal Enema or Placebo Enema

Cohort 2

OTHER

Drug: PUR 0110 Rectal Enema or Placebo Enema

Cohort 3

OTHER

Drug: PUR 0110 Rectal Enema or Placebo Enema

Cohort 4

OTHER

Drug: PUR 0110 Rectal Enema or Placebo Enema

Interventions

PUR 0110 Rectal Enema or Placebo Enema DRUG

187.5 mg/60 g

Also known as: PUR 0110 Enema, PUR 0110

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PurGenesis Technologies Inc.: lead

Study Sites (1)

FOCUS Clinical Drug Development GmbH Phase 1 Clinic

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Theophilus J Gana, MD, PhD

  PurGenesis Technologies Inc.

  STUDY DIRECTOR

• Sergej Berger, MD

  FOCUS Clinical Drug Development GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 24, 2010

Record last verified: 2010-06

Locations

DE (1)