Study to Investigate the Regional Drug Absorption of KUC-7483 CL Administered Via an Enterion™ Capsule Compared to an Immediate Release Formulation in Healthy Male Volunteers
Study to Investigate the Regional Drug Absorption of KUC-7483 CL Administered Via an Enterion™ Capsule Compared to an Immediate Release Formulation in Healthy Male Volunteers
Study to determine and compare the absorption of KUC 7483 CL from different regions of the GI
 tract with the immediate release formulation and to compare the absorption of particulate
 versus solution formulations from the ascending colon
Inclusion Criteria:

 1. Healthy males, according to the following criteria:

 Based upon a complete medical history, including the physical examination, vital signs
 (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests

 -  No clinically significant findings

 -  No evidence of a clinically relevant concomitant disease

 2. Age ≥18 and ≤65 years

 3. BMI ≥18.5 and ≤29.9 kg/m2

 4. Subjects must be able to demonstrate the ability to swallow an empty size 000 gelatin
 capsule

 5. Signed and dated written informed consent prior to admission to the study in
 accordance with Good Clinical Practice and the local legislation

 Exclusion Criteria:

 1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
 immunological or hormonal disorders

 2. History of gastrointestinal surgery, with the exception of Appendicectomy unless it
 was performed within the previous 12 months

 3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
 neurological disorders

 4. History of relevant orthostatic hypotension, fainting spells or blackouts

 5. Chronic or relevant acute infections

 6. History of allergy/hypersensitivity (including drug allergy) to any drug including the
 study drug (KUC-7483 CL) and similar drugs which is deemed relevant to the trial as
 judged by the investigator

 7. Use of prescription or non-prescription drugs (including vitamins and natural herbal
 remedies e.g. St Johns Wort) from 14 days prior to the start of the study until the
 end of the final study period. Occasional use of paracetamol (up to 4g per day) is
 permitted throughout the study

 8. Participation in another trial with an investigational drug within four months prior
 to administration or during the trial

 9. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day). A breath carbon monoxide
 reading of greater than 20ppm

 10. Inability to refrain from smoking on trial days

 11. Regular alcohol consumption >21 units per week units per week (1 Unit = ½ pint beer, a
 25ml shot of 40% spirit or a 125ml glass of wine)

 12. Subjects who have ever sought advice from a physician or counselor for abuse or misuse
 of alcohol, non-medicinal drugs or other substances of abuse e.g. solvents

 13. Any current or previous use of Class A drugs such as opiates, cocaine, ecstasy,
 lysergic acid diethylamide, and amphetamines (Class B).

 Volunteers who admit to occasional past use of cannabis will not be excluded as long
 as they have a negative drugs of abuse test and have been abstinent for at least 12
 months

 14. Positive drugs of abuse result

 15. Blood donation (more than 100 mL within three months prior to administration or during
 the trial)

 16. Excessive physical activities outside a subjects normal routine (within one week prior
 to administration or during the trial until after the post-study medical)

 17. Unable to eat all elements of a standard meal

 18. Any laboratory value outside the reference range of clinical relevance as determined
 by the Investigator

 19. Radiation exposure from clinical trials, including that from the present study and
 from diagnostic X-rays but excluding background radiation, exceeding 5mSv in the last
 twelve months or 10mSv in the last five years. No subject whose occupational exposure
 is monitored will participate in the study

 20. Acute diarrhea, or constipation in the 14 days before the predicted first study day.
 If screening occurs >14 days before first study day, this criterion is to be
 determined on first study day. Diarrhea will be defined as the passage of liquid
 faeces and/or a stool frequency of greater than three times per day. Constipation will
 be defined as a failure to open the bowels more frequently than every other day

 21. Presence of non-removable metal objects such as metal plates, screws etc. in abdominal
 region of the body

 22. Subjects will be excluded from the study if they are considered by the investigator to
 be at risk of transmitting through blood and other body fluids the agents responsible
 for AIDS (Acquired Immunodeficiency Syndrome) or other sexually transmitted disease or
 hepatitis. This will be achieved by the use of a card (similar to that used by the
 National Blood Transfusion Service) which asks a potential subject if they have reason
 to believe that they may fall into any category included on the card. If the verbal
 answer is in the affirmative then they will be excluded from the study

 23. Positive hepatitis B virus, hepatitis C virus or HIV results