Colonic Diseases Clinical Trial
Official title:
A Double-Blind, Placebo Controlled, Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GIC-1001 in Normal Healthy Volunteers
Verified date | July 2013 |
Source | gicare Pharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I clinical study are to evaluate the safety and tolerability of five (5) single and four (4) multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80 healthy, 18-50 years old male and female subjects. Moreover, the effect of food on the pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed with an integrated, adaptive approach which allows the evaluation of single and multiples doses of GIC-1001 in a progressive, overlapped fashion.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Male or female volunteer 2. A female volunteer must meet one of the following criteria: 1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from the screening visit until 2 months after the last drug administration. or 2. Participant is of non-childbearing potential, defined as a female who had had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses) 3. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must meet the following criterion: Participant agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration. 4. Volunteer aged of at least 18 years but not older than 50 years 5. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30 kg/m2 6. Non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study 7. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance 8. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis) Exclusion Criteria: 1. History of significant hypersensitivity to trimebutine, to sulfur containing drugs (e.g. Captopril) or any related products (including excipients of the formulation) as well as severe hypersensitivity reactions (like angioedema) to any drugs 2. Presence of significant gastrointestinal, liver/kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects 3. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability 4. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease 5. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases 6. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS <60 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities 7. Known presence of rare hereditary problems of galactose and /or lactose intolerance 8. Use of cysteine, methionine, and other sulfur containing amino acid supplements in the previous 7 days before day 1 of this study 9. Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) 10. Any clinically significant illness in the previous 28 days before day 1 of this study 11. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study 12. Any history of tuberculosis and/or prophylaxis for tuberculosis 13. Positive urine screening of ethanol and/or drugs of abuse 14. Positive results to HIV, HBsAg or anti-HCV tests 15. Females who are pregnant according to a positive serum pregnancy test 16. Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Algorithme Pharma Inc. | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
gicare Pharma Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in physical status | Safety and Tolerability Monitoring: changes from baseline in blood pressure, pulse rate, oxygen saturation of blood, and body temperature will be measured at 8 hours post drug administration. | 8 hours post- drug administration | Yes |
Secondary | Pharmacokinetics | Blood samples will be obtained over a 36 hour period in the single dose portion of the study and over 7 days, every morning prior to GIC-1001, as well as 8 hours post-last dose in the multiple dosing phase. Main absorption and disposition parameters using a non-compartmental approach will be measured. For GIC-1001 and its metabolites, the pharmacokinetic parameters of interest for the single dose regimens will be Cmax, AUC0-8, AUCT, AUC8, Tmax, AUCT/8, Kel, T½el, Cl/F and Vd/F. The parameters Cmax, AUC0-8, AUCT and AUC8 will be dose-normalized, and their natural logarithm will be calculated. The pharmacokinetic parameters of interest for the multiple dose regimens will be Cmax, Tmax, AUCt, Cmin, Cpds, Fluctuation and Swing. The parameters Cmax, AUCt and Cmin will be dose-normalized, and the natural logarithm of Cmax, AUCt, Cmin and Cpds of will be calculated. For hydrogen sulfide and thiosulfate, the pharmacokinetic parameters of interest will be Cmax, Tmax and AUC0-4. |
Up to 36 hours for single ascending doses; every day and up to 8 hour post last dose for multiple ascending doses | No |
Secondary | Change in ECG recording | Safety and Tolerability Monitoring: In all cohorts, change from baseline of 12-lead ECG will be measured at 3 hours post-drug administration. | 3 hours post drug administration | Yes |
Secondary | Cardiac monitoring | Safety and Tolerability Monitoring: During Single Ascending Dosing only, continuous cardiac monitoring will be performed from approximately 1 hour prior to drug administration until at least 23 hours post-dose. In cases where the alarm activation of the monitoring system takes place for notification of concerns and/or rhythm changes, a rhythm strip will be printed and filed as source data. These occurrences will be followed up through further medical investigation, and/or filing of AEs. Any interruption of the patient monitoring due to clinical activities or else will be documented. |
23 hours post drug administration | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02503696 -
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
|
N/A | |
Terminated |
NCT01119027 -
Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills
|
N/A | |
Completed |
NCT01063231 -
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
|
Phase 3 | |
Completed |
NCT04074577 -
Computer Aided Detection, Tandem Colonoscopy Study
|
N/A | |
Not yet recruiting |
NCT04087824 -
Deep Learning Algorithm for Recognition of Colonic Segments.
|
N/A | |
Completed |
NCT03559543 -
Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma
|
Phase 2 | |
Terminated |
NCT02503631 -
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
|
||
Completed |
NCT01600209 -
Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
|
N/A | |
Completed |
NCT01260168 -
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
|
N/A | |
Completed |
NCT00604162 -
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
|
Phase 3 | |
Recruiting |
NCT04598880 -
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
|
Phase 4 | |
Completed |
NCT04080843 -
Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients
|
Phase 2 | |
Terminated |
NCT04644315 -
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
|
Phase 2 | |
Completed |
NCT02291445 -
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
|
Phase 2 | |
Completed |
NCT03037385 -
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03139942 -
Optical Polyp Testing for In Vivo Classification
|
N/A | |
Completed |
NCT04263818 -
Endoscopist and Endoscope Motions During Colonoscopy
|
N/A | |
Recruiting |
NCT05923918 -
A Study to Evaluate Safety and Efficacy of PBK_M2101
|
Phase 3 | |
Completed |
NCT02647866 -
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT01397747 -
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
|
N/A |