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

Colorectal Cancer Clinical Trial

— OUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834742
• Other study ID #: NER1006-01/2011 (OUT)
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2013
• Last updated: April 15, 2013
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. The subject's written informed consent must be obtained prior to inclusion.

2. Healthy subjects with an age of 18 to 45 years.

3. 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.

4. 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.

5. Willing, able and competent to complete the entire procedure and to comply with study instructions.

Exclusion Criteria:

1. Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.

2. 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).

3. Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.

4. 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]).

5. Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.

6. 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.

7. Known glucose-6-phosphatase dehydrogenase deficiency.

8. Known phenylketonuria.

9. History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.

10. History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.

11. History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.

12. Evidence of dehydration.

13. Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.

14. 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.

15. Clinically relevant findings on physical examination based on Investigator's judgement.

16. Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.

17. Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.

18. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.

19. Subjects who are unwilling to comply with the provisions of the study protocol.

20. Concurrent participation in an investigational drug study or participation within 3 month of study entry.

21. Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.

22. Previous participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• NER1006
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.
• NER1006
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
• NER1006
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
• Moviprep
Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
• NER1006
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
• NER1006
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
• NER1006
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
• NER1006
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.

Locations

Country	Name	City	State
Romania	Pierrel Research HP-RO-SRL	Timisoara
Romania	Pierrel Research HP-RO-SRL	Timisoara

Sponsors (2)

Lead Sponsor	Collaborator
Norgine	Pierrel Research Europe GmbH

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Variable	Stool weight output generated from the start of intake for the following 24 hours.	36 Hours	No
Secondary	PEG3350 concentration	Concentration of PEG3350 in blood, urine and faeces.	96 Hours	Yes
Secondary	Sulphate concentration	Concentration of PEG3350 in blood, urine and faeces.	96 hours	No
Secondary	Ascorbic acid concentration	Concentration of ascorbic acid in blood, urine and faeces.	96 hours	No
Secondary	Electrolytes concentration	Concentration of electrolytes in blood, urine and faeces.	96 hours	No
Secondary	Safety profile	Spontaneouly reported adverse events will be recorded throughout the study	96 hours	No