GASTROINTESTINAL DISORDERS
Our Experience
- Over 100 Phase I/II PK or PD studies involving drugs acting locally in the gastrointestinal (GI) tract or systemically:
- Antacids and mucosal protective agents
- Gastric antisecretory (anti-H2 and PPIs)
- GI motility (cisapride and cisapride-like)
- Dissolution of gallstones
- Inflammatory bowel disease treatment
- Pharmacokinetic assessments on locally acting drugs despite the low bioavailability of the drug
- Assessment of GI pharmacodynamics response using:
- Measurement of intra-gastric pH
- Rectal biopsy
- Visceral pain model using the barostat method to assess rectal distension and rectal sensory threshold
- Endoscopy
- Colonoscopy
- Full clinical pharmacology program for a new prokinetic agent from FIH to DDI; and renal impairment
Case Studies
- A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
- An interaction study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
- A study to evaluate safety, tolerability and pharmacokinetics of trimebutine 3-Thiocarbamoylbenzenesulfonate (GIC-1001) in a randomized phase I integrated design study: single and multiple ascending doses and effect of food in healthy volunteers
- A Phase 1b Clinical Study on the Analgesic Effect of NCE on Visceral Pain under Rectal Distension and Rectal Sensory Threshold using the Barostat Method in Male and Female Healthy Volunteers
- A study to evaluate the effect of food and formulation on the relative bioavailability of bismuth biskalcitrate, metronidazole and tetracycline given for Helicobacter pylori eradication
Patient Access
- 250+ patients with ileostomy
- 250+ patients with ulcerative colitis
- 250+ patients with Crohn’s disease
- 700+ patients with irritable bowel syndrome
- 4000+ patients with gastroesophageal reflux disease (GERD)
- Searchable database to qualify Inclusion/Exclusion criteria for pre-existing conditions, demographics, medication use and BMI
Clinical Expertise
- Medical expertise and the support of a gastroenterologist with 20+ years of experience in Phase I/II clinical research
- Administration of different types of formulations (oral, suppository, rectal gel, enema, gastro-retentive capsule, etc.)
- GI condition assessment techniques such as endoscopy, colonoscopy, radiology and X-ray imaging with barium, barostat, microbial and intragastric pH measurement
- Experience with swallowability and palatability assessment