A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Pancrelipase; Pancrelipase
Intervention description: Delayed release capsules; Delayed release capsules
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Creon; Pancrelipase; ABT-SLV-245; Exocrine Pancreatic Insufficiency (EPI)

Summary:

      Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules
      manufactured with a modernized process (MP) is non-inferior to currently marketed
      pancrelipase DR capsules in participants with exocrine pancreatic insufficiency (EPI) due to
      cystic fibrosis (CF), as measured by coefficient of fat absorption (CFA). Part 2 is a study
      to demonstrate that Creon (pancrelipase) manufactured with an alternate active pharmaceutical
      ingredient site (AAPIS) is non-inferior to currently marketed active control (Creon®) in
      participants with EPI due to CF, as measured by CFA. Safety is evaluated in each part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a documented diagnosis of Cystic Fibrosis (CF) confirmed by:

               -  a sweat chloride test >= 60 mmol/L, and/or

               -  documented CF-causing cystic fibrosis transmembrane conductance regulator (CFTR)
                  mutations and clinical features of CF.

          -  Participant has diagnosis of moderate to severe Exocrine Pancreatic Insufficiency
             (EPI), as determined by Fecal Elastase 1 (FE-1) < 15 μg/g at screening.

          -  Participant has EPI that is currently clinically controlled (no clinically overt
             steatorrhea or diarrhea) under treatment with a commercially available Pancreatic
             Enzyme Replacement Therapy (PERT), on an individually established dose regimen for
             more than 3 months prior to Screening, with a daily dose not exceeding 4,000 Lipase
             Units (LU)/g fat/day or 10,000 LU/kg/day.

          -  Participant is available for two (if participating in one of the parts) or four (if
             participating in both parts) hospitalization/confinement periods of 6 to 8 days each
             during the expected study window.

          -  Participant is able to consume a diet with 100 g fat/day, a minimum of 1 g/kg of
             protein/day and normal to low fiber content.

        Exclusion Criteria:

          -  BMI percentile for age less than 10% in participants less than 18 years of age.

          -  Participant has a history of any of the following gastrointestinal disorders (acute
             pancreatitis within 6 months prior to Visit 2, chronic pancreatitis, fibrosing
             colonopathy, distal intestinal obstruction syndrome (DIOS) within 6 months prior to
             Visit 2, C. difficile infection within 6 months prior to Visit 2, celiac disease,
             gastric bypass or partial/total gastrectomy, Crohn's disease or other inflammatory
             bowel disease, small bowel surgery (other than minor resection due to meconium ileus
             without resultant malabsorption syndrome), or any type of malignancy involving the
             digestive tract in the last 5 years).

          -  Participant has a history of any clinically significant endocrine, respiratory (except
             mild asthma or CF related lung disease), neurological, cardiac, renal, hepatic
             (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any
             other uncontrolled medical illness which might limit participation in or completion of
             the study.

          -  Participant requires concomitant treatment with any medication not allowed by the
             protocol or a prohibited medication is expected to be needed during the study.

          -  Participant is currently receiving nutritional supplementation via tube feeding
             (nasogastric, gastrostomy, jejunostomy).

          -  Participant has clinically significant (as per Investigator's judgment) abnormalities
             in clinical chemistry, hematology, or urinalysis (excluding findings that are
             associated with CF) such as aspartate aminotransferase (AST) or alanine
             aminotransferase (ALT) levels >= 3 times the upper limit of normal values, or
             clinically significant (investigator opinion) elevation of uric acid.