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

NCT02259920 | Completed Phase 1

• 1 other identifier: 1207.2
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 24 hours after drug administration

Secondary Outcomes (12)

• Cmax(maximum measured concentration of the analyte in plasma)

  up to 24 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 24 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  up to 24 hours after drug administration

• λz (terminal rate constant of the analyte constant in plasma)

  up to 24 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 24 hours after drug administration

Study Arms (5)

Treatment A

ACTIVE COMPARATOR

KUC 4783 CL, immediate release tablets

Drug: KUC 7483 CL, immediate release tablet

Treatment B

EXPERIMENTAL

KUC 4783 CL delivered as a particulate formulation to the distal small bowel

Drug: KUC 7483 CL, particulate formulation; Device: Enterion™ capsule

Treatment C

EXPERIMENTAL

KUC 4783 CL delivered as a particulate formulation to the ascending colon

Drug: KUC 7483 CL, particulate formulation; Device: Enterion™ capsule

Treatment D

EXPERIMENTAL

KUC 4783 CL delivered as a solution formulation to the ascending colon

Drug: KUC 7483 CL, solution formulation; Device: Enterion™ capsule

Treatment E

EXPERIMENTAL

KUC 4783 CL delivered as a solution formulation to the descending colon

Drug: KUC 7483 CL, solution formulation; Device: Enterion™ capsule

Interventions

KUC 7483 CL, immediate release tablet DRUG

Treatment A

KUC 7483 CL, particulate formulation DRUG

Treatment B; Treatment C

KUC 7483 CL, solution formulation DRUG

Treatment D; Treatment E

Enterion™ capsule DEVICE

Treatment B; Treatment C; Treatment D; Treatment E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥18 and ≤65 years
• BMI ≥18.5 and ≤29.9 kg/m2
• Subjects must be able to demonstrate the ability to swallow an empty size 000 gelatin capsule
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• History of gastrointestinal surgery, with the exception of Appendicectomy unless it was performed within the previous 12 months
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• 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
• 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
• Participation in another trial with an investigational drug within four months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day). A breath carbon monoxide reading of greater than 20ppm
• Inability to refrain from smoking on trial days
• 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)
• 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
• 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
• Positive drugs of abuse result

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 9, 2014
• Study Start: December 1, 2003
• Primary Completion: May 1, 2004
• Last Updated: October 9, 2014

Record last verified: 2014-10