CompletedPhase 1

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

Germany24 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

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

Timeframe: After single-ascending doses

Trial details

NCT IDNCT01149694

SponsorPurGenesis Technologies Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08