Back to resultsA Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
PUR 0110 Rectal Enema or Placebo Enema
PUR 0110 Rectal Enema or Placebo Enema
PUR 0110 Rectal Enema or Placebo Enema
PUR 0110 Rectal Enema or Placebo Enema
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring PurGenesis Technologies Inc., PUR 0110 rectal enema, Ulcerative colitis, Distal, Normal healthy volunteers
Eligibility 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.
Sites / Locations
- FOCUS Clinical Drug Development GmbH Phase 1 Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
Outcomes
Primary Outcome Measures
Incidence, nature and severity of adverse events and abnormal clinical laboratory test results
Secondary Outcome Measures
Maximum tolerated dose (MTD)
Pharmacokinetic profile and parameters - if specific pharmacokinetic markers are successfully identified
Full Information
NCT ID
NCT01149694
First Posted
June 22, 2010
Last Updated
June 23, 2010
Sponsor
PurGenesis Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01149694
Brief Title
A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PurGenesis Technologies Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Flexible sigmoidoscopy will be performed during the Screening Period within 72 to 48 hours pre-dose and within 9 +/- 1 hours post-dosing to visually examine the colonic mucosa for any signs of local toxicity and grade it as normal/abnormal; and 3 pinch biopsies will be obtained at each endoscopy at about the same level in the colon (<50 cm from the anal verge) for histology. At the baseline flexible sigmoidoscopy, subjects must have normal colonic and rectal mucosa (i.e., no bleeding, inflammation, edema, ulceration or other abnormal finding) to be included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
PurGenesis Technologies Inc., PUR 0110 rectal enema, Ulcerative colitis, Distal, Normal healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Other
Arm Title
Cohort 2
Arm Type
Other
Arm Title
Cohort 3
Arm Type
Other
Arm Title
Cohort 4
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
PUR 0110 Rectal Enema or Placebo Enema
Other Intervention Name(s)
PUR 0110 Enema, PUR 0110
Intervention Description
187.5 mg/60 g
Intervention Type
Drug
Intervention Name(s)
PUR 0110 Rectal Enema or Placebo Enema
Other Intervention Name(s)
PUR 0110 Enema, PUR 0110
Intervention Description
375 mg/60 g
Intervention Type
Drug
Intervention Name(s)
PUR 0110 Rectal Enema or Placebo Enema
Other Intervention Name(s)
PUR 0110 Enema, PUR 0110
Intervention Description
750 mg/60 g
Intervention Type
Drug
Intervention Name(s)
PUR 0110 Rectal Enema or Placebo Enema
Other Intervention Name(s)
PUR 0110 Enema, PUR 0110
Intervention Description
1500 mg/60 g
Primary Outcome Measure Information:
Title
Incidence, nature and severity of adverse events and abnormal clinical laboratory test results
Time Frame
After single-ascending doses
Secondary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Time Frame
After single-ascending doses
Title
Pharmacokinetic profile and parameters - if specific pharmacokinetic markers are successfully identified
Time Frame
After single-ascending doses
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theophilus J Gana, MD, PhD
Organizational Affiliation
PurGenesis Technologies Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergej Berger, MD
Organizational Affiliation
FOCUS Clinical Drug Development GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
FOCUS Clinical Drug Development GmbH Phase 1 Clinic
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
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A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
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