Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Protocol ALCT-0000497 consists of three distinct study periods as follows:

1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.

2. In Period B (11 days), subjects will be randomized to either Group A (active
investigational then placebo control) or Group B (placebo control then active
investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day
washout period between Days 1 and 9, subjects will receive Peptamen 1.5.

3. In Period C (9 days), subjects will receive RELiZORB during nocturnal enteral feedings
with Impact Peptide 1.5.

Inclusion Criteria:

1. Confirmed CF diagnosis with 2 clinical features

2. Documented history of EPI

3. Enteral formula use minimum of 4x/week

4. Written informed consent or assent

Exclusion Criteria:

1. Uncontrolled diabetes mellitus

2. Signs and symptoms of liver cirrhosis or portal hypertension

3. Lung/liver transplant

4. Active cancer currently receiving cancer treatment

5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant,
inflammatory bowel disease

6. DIOS or fibrosing colonopathy