Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

NCT01834742 | Completed Phase 1

• 1 other identifier: NER1006-01/2011 (OUT)
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.

Conditions

Colorectal Cancer

Keywords

Moviprep; PEG3350; Laxative; Stool Output

Outcome Measures

Primary Outcomes (1)

• Primary Variable

  Stool weight output generated from the start of intake for the following 24 hours.

  36 Hours

Secondary Outcomes (5)

• PEG3350 concentration

  96 Hours

• Sulphate concentration

  96 hours

• Ascorbic acid concentration

  96 hours

• Electrolytes concentration

  96 hours

• Safety profile

  96 hours

Study Arms (8)

Part A, arm 1

EXPERIMENTAL

Evening dose 1 plus fixed morning dose

Drug: NER1006

Part A, arm 2

EXPERIMENTAL

Evening dose 2 plus fixed morninf does

Drug: NER1006

Part A, arm 3

EXPERIMENTAL

Evening dose 3 plus fixed morning dose

Drug: NER1006

Part A, arm 4

ACTIVE COMPARATOR

Moviprep

Drug: Moviprep

Part B, arm 1

EXPERIMENTAL

Fixed evening dose plus morning dose 1

Drug: NER1006

Part B, arm 2

EXPERIMENTAL

Fixed evening dose plus morning dose 2

Drug: NER1006

Part B, arm 3

EXPERIMENTAL

Fixed evening dose plus morning dose 3

Drug: NER1006

Part B, arm 4

EXPERIMENTAL

Fixed evening dose plus alternative morning dose

Drug: NER1006

Interventions

NER1006 DRUG

Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

Part A, arm 1

Moviprep DRUG

Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.

Part A, arm 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects with an age of 18 to 45 years.
• Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
• Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in.
• Willing, able and competent to complete the entire procedure and to comply with study instructions.

You may not qualify if:

• Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
• Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs \[NSAID\], acetaminophen or metamizole).
• Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
• Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome \[IBS\], inflammatory bowel disease \[IBD\]).
• Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
• History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
• Known glucose-6-phosphatase dehydrogenase deficiency.
• Known phenylketonuria.
• History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
• History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
• History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
• Evidence of dehydration.
• Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
• Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
• Clinically relevant findings on physical examination based on Investigator's judgement.

Sponsors & Collaborators

• Norgine: lead
• Pierrel Research Europe GmbH: collaborator

Study Sites (2)

Pierrel Research HP-RO-SRL

Timișoara, 300244, Romania

Location

Pierrel Research HP-RO-SRL

Timișoara, Romania

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rodica Cinca, MD

  Pierrel Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

RO (2)