A clinical phase I study on GIC-1001 in healthy volunteers
- Conditions
- Gastroenterology/pain management/management of visceral pain during sedation-free colonoscopyDigestive System
- Registration Number
- ISRCTN09480239
- Lead Sponsor
- gIcare Pharma Inc (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Male or female volunteer
2. A female volunteer must meet one of the following criteria:
2.1. 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. Additionally, if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception from first drug administration until 2 months after the last drug administration. OR
2.2. 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. An acceptable method of contraception includes one of the following: Abstinence from heterosexual intercourse or condom with spermicide
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability: Single and multiple (7 consecutive days) doses<br>In this Phase I study, 5 single ascending doses of GIC-1001 will be studied, as well as 4 multiple doses administered during 7 consecutive days ( TID regimen). As well, one single dose will be administered with and without food to assess the effect of food intake on the PK of the study drug. Safety issues monitored.
- Secondary Outcome Measures
Name Time Method