Ulcerative ColitisPhase 1NCT01149694
A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
A Phase 1 study of Ulcerative Colitis, run by PurGenesis Technologies Inc. at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
FOCUS Clinical Drug Development GmbH Phase 1 Clinic
Neuss, 41460
About this study
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
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- PUR 0110 Rectal Enema or Placebo Enema
- Keywords
- PurGenesis Technologies Inc., PUR 0110 rectal enema, Ulcerative colitis, Distal, Normal healthy volunteers
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR 0110 Rectal Enema or Placebo EnemaDrug
Also called PUR 0110 Enema, PUR 0110
187.5 mg/60 g
PUR 0110 Rectal Enema or Placebo EnemaDrug
Also called PUR 0110 Enema, PUR 0110
375 mg/60 g
PUR 0110 Rectal Enema or Placebo EnemaDrug
Also called PUR 0110 Enema, PUR 0110
750 mg/60 g
PUR 0110 Rectal Enema or Placebo EnemaDrug
Also called PUR 0110 Enema, PUR 0110
1500 mg/60 g
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Not described Receives: Drug: PUR 0110 Rectal Enema or Placebo Enema |
| Cohort 2 | Other | Not described Receives: Drug: PUR 0110 Rectal Enema or Placebo Enema |
| Cohort 3 | Other | Not described Receives: Drug: PUR 0110 Rectal Enema or Placebo Enema |
| Cohort 4 | Other | Not described Receives: Drug: PUR 0110 Rectal Enema or Placebo Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature and severity of adverse events and abnormal clinical laboratory test results
Measured: After single-ascending doses
Secondary outcomes (2)
Maximum tolerated dose (MTD)
Measured: After single-ascending doses
Pharmacokinetic profile and parameters - if specific pharmacokinetic markers are successfully identified
Measured: After single-ascending doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PurGenesis Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Theophilus J Gana, MD, PhD, Study director, PurGenesis Technologies Inc.Sergej Berger, MD, Principal investigator, FOCUS Clinical Drug Development GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149694
- Sponsor's protocol ID
- PG08-PUR 0210-FIM001
- Other IDs
- 2009-010405-36, 2009
- Status last verified
- Jun 2010
- First submitted
- 22 Jun 2010
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01149694
- Acronym / sponsor ID
- PG08-PUR 0210-FIM001
- Conditions
- Ulcerative Colitis
- Keywords
- PurGenesis Technologies Inc., PUR 0110 rectal enema, Ulcerative colitis, Distal, Normal healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PurGenesis Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUR 0110 Rectal Enema or Placebo EnemaAlso: PUR 0110 Enema, PUR 0110187.5 mg/60 g | Drug | Cohort 1 |
| PUR 0110 Rectal Enema or Placebo EnemaAlso: PUR 0110 Enema, PUR 0110375 mg/60 g | Drug | Cohort 2 |
| PUR 0110 Rectal Enema or Placebo EnemaAlso: PUR 0110 Enema, PUR 0110750 mg/60 g | Drug | Cohort 3 |
| PUR 0110 Rectal Enema or Placebo EnemaAlso: PUR 0110 Enema, PUR 01101500 mg/60 g | Drug | Cohort 4 |
Primary outcome
Incidence, nature and severity of adverse events and abnormal clinical laboratory test results
Time frame: After single-ascending doses
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theophilus J Gana, MD, PhD study director
PurGenesis Technologies Inc.
Sergej Berger, MD principal investigator
FOCUS Clinical Drug Development GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Ulcerative Colitis, run by PurGenesis Technologies Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature and severity of adverse events and abnormal clinical laboratory test results (time frame: After single-ascending doses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2010.