An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis.
- Conditions
- ulcerative colitisMedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis
- Registration Number
- EUCTR2007-005520-32-NL
- Lead Sponsor
- GlaxoSmithKline R&D Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.A history of UC for at least 3 months, with the diagnosis confirmed by radiologic, endoscopic or histological assessment.
2.Has moderately active UC, either stable on medications or in a flare of the disease.
3.Must have documented Mayo endoscopic score of 2 within 2 days of dosing.
4.Male or female between 18 and 65 years of age at the time of the screening visit.
5.A female subject is eligible to participate if she is of:
•Non-childbearing potential
•Child-bearing potential and agrees to use one of the contraception methods listed in protocol.
6.Male subjects must agree to use one of the contraception methods listed in protocol.
7.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within twice (2x) the upper limit of normal as screening and bilirubin within 1.25x ULN at screening.
8.Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
9.QTcB or QTcF < 450 msec at screening/baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
2.A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
3.A positive test for HIV antibody.
4.History of regular alcohol consumption within 6 months of the study defined as in protocol.
5.The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
6.Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
7.Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
8.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
9.Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
10.Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
11.Lactating females.
12.Unwillingness or inability to follow the procedures outlined in the protocol.
13.Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
14.Mild or severe UC, Mayo endoscopic score of 0 to 1 or 3.
15.Toxic megacolon or perforation on plain abdominal Xray.
16.Crohn’s Disease, indeterminate colitis, bleeding disorders, or active ulcer disease.
17.Previous colonic surgery.
18.Current or recurrent disease, other than UC, that could affect the action, absorption or disposition of the study medication, or clinical or laboratory assessments.
19.Absolute neutrophil count below 2.0x109/L.
20.A positive culture for enteric pathogens that is clinically significant, presence of clostridium difficile toxin, or with ova and parasites detected by microscopy, or has a clinical suspicion of an infectious disease of the bowel.
21.Symptomatic GI stricture within 6 months of screening or obstructive symptoms within 3 months of screening.
22.Likely to require abdominal surgery within the study period.
23.Congenital or acquired immunodeficiency, including any immunologic diseases with gastrointestinal involvement except for UC.
24.Ongoing neoplastic disease of the bowel.
25.History of prostatitis, epididymitis, epididymal cysts, structural abnormalities or testicular cancer.
26.Subjects with abnormalities of the renal tract, renal stones or history of recurrent urinary tract infections (UTI.s).
27.Subjects with any history of autoimmune hepatitis or sclerosing cholangitis.
28.Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burd
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method