Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00748410
• Date of registration: 05/09/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis
• Scientific title: An Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis.
• Date of first enrolment: January 22, 2009
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00748410
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- A history of ulcerative colitis for at least 3 months

- moderately active UC, either stable on medications or in a flare of the disease

- Mayo endoscopic score of 2 or 3 within 2 days of dosing.

- Male or female between 18 and 65 years of age

- Women of child bearing potential must use an effective method of contraception.

- Male subjects must agree to use one of the specified contraception method,

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal at study
start.

- Signed written informed consent

- QTcB or QTcF < 450msec at screening

Exclusion criteria:

- The subject has a positive pre-study drug/alcohol screen.

- A positive test for HIV, hepatitis B or C.

- History of regular alcohol consumption within 6 months of the study

- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements within 7 days or 5 half-lives prior to the first dose of study medication

- Known allergies

- recent participation in another trial

- recent blood donation

- Pregnant or lactating females

- unwillingness or inability to follow study procedures

- consumption of red wine, seville oranges, grapefruit or grapefruit juice in last 7
seven day before study start.

- Mild UC, Mayo endoscopic score of 0 or 1.

- Toxic megacolon or perforation on plain abdominal Xray.

- Crohn's Disease, indeterminate colitis, bleeding disorders, or active ulcer disease.

- Previous colonic surgery.

- Current or recurrent disease, other than UC, that could affect the action, absorption
or disposition of the study medication, or clinical or laboratory assessments.

- Absolute neutrophil count below 2.0x109/L.

- 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.

- Symptomatic GI stricture within 6 months of screening or obstructive symptoms within 3
months of screening.

- Likely to require abdominal surgery within the study period.

- Congenital or acquired immunodeficiency, including any immunologic diseases with
gastrointestinal involvement except for UC.

- Ongoing neoplastic disease of the bowel.

- History of prostatitis, epididymitis, epididymal cysts, structural abnormalities or
testicular cancer.

- Subjects with abnormalities of the renal tract, renal stones or history of recurrent
urinary tract infections (UTI.s).

- Subjects with any history of autoimmune hepatitis or sclerosing cholangitis. Previous
inclusion in a research and/or medical protocol involving nuclear medicine, PET or
radiological investigations with significant radiation burden.

- Blood pressure persistently = 140/90 mmHg at screening

- Concurrent illness or disability that may affect the interpretation of clinical data,
or otherwise contraindicates participation in this clinical study (e.g., an unstable
cardiovascular, autoimmune, renal, pulmonary, hepatic, endocrine, metabolic,
haematological, or neurological condition).

- Clinically significant hepatic impairment(Evidence of cirrhosis, Clinical episodes of
jaundice)

- Current evidence of, or has been treated for a malignancy within the past 5 years.

- BMI <18 kg.m2 or >35 kg/m2

- Clinically significant renal laboratory values.

- Has not discontinued any prohibited concomitant medication prior to the screening
visit or within the protocol-specified time period.

- Has not remained on a stable dose of any permitted concomitant medication(s) for the
protocol-specified time period preceding the Screening Visit.

- history of substance abuse



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: SB-656933

Primary Outcome(s)

Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS) [Time Frame: Baseline (Day -1) and Day 1 and 7]

Secondary Outcome(s)

Changes From Baseline to After Treatment in Faecal Calprotectin Levels [Time Frame: Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to follow-up (7 to 10 days after last dose)]

Vital Signs Assessment- Heart Rate [Time Frame: Day 1 and 7]

Amount of Medicine in Blood [Time Frame: At 1, 2.25, 4, 8 hour on Day 1 and 7]

Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Time Frame: Day 1 and 7]

Secondary ID(s)

CUC111342

2007-005520-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00748410