A Phase 1, Food & Proton Pump Inhibitor Effect on GED-0301 PK study
Research type
Research Study
Full title
A PHASE 1, OPEN LABEL, SINGLE CENTER, RANDOMIZED, SIX SEQUENCE, CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD, FORMULATION STRENGTH, AND A PROTON PUMP INHIBITOR ON GED-0301 PHARMACOKINETICS IN HEALTHY ADULT SUBJECTS
IRAS ID
216966
Contact name
Ulrike Lorch
Contact email
Eudract number
2016-003424-23
Duration of Study in the UK
0 years, 2 months, 26 days
Research summary
We are conducting a food effect and bioavailability study with the investigational drug GED-0301 and marketed drug omeprazole. GED-0301 is being developed by Celgene Corporation as a treatment for Crohn’s disease (a serious disease affecting the digestive system). Omeprazole reduces stomach acid and is commonly used to treat stomach conditions such as stomach ulcers and acid reflux.
Medications currently used to treat Crohn’s disease are often ineffective or limited by significant side effects. GED-0301 has been trialled in over 130 Crohn’s patients and demonstrated a good safety profile and negligible systemic absorption.In this study, we want to evaluate food effect on a new 160 mg formulation of GED 0301 and relative bioavailability of the new 160 mg formulation compared to the original 40 mg formulation. Additionally, the effect of a proton pump inhibitor (omeprazole, which increases stomach pH) on the PK of GED 0301 will also be evaluated as the GED 0301 formulation is a gastro-resistant, delayed release, pH-dependent tablet.
In this study, eighteen healthy volunteers will receive the following four treatments: (A) a single 160mg tablet of GED-0301 fasted; (B) a single 160mg tablet of GED-001 fed; (C) four 40mg tablets GED-0301 fasted; (D) six daily doses of omeprazole 40mg with a single 160 mg tablet of GED-0301 on the fifth day, fasted. The order of the treatment periods will be randomly allocated, although Treatment D will always be given in the fourth period. The screening period is up to 21 days and the overall duration of the treatment period is seventeen days, with a follow-up phone call five days after discharge.
We will assess safety parameters including physical examination, vital sign measurements, laboratory evaluations, electrocardiogram (ECG) and monitoring of adverse events. Information obtained in this study may help optimise administration requirements for GED-0301 in Crohn’s patients.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0575
Date of REC Opinion
23 Nov 2016
REC opinion
Further Information Favourable Opinion