Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Omeprazole

Criteria

Inclusion criteria:

• Healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Subjects will be either Caucasian or Japanese (first generation Japanese: born in Japan with parents of Japanese descent, and not more than 5 years out of Japan, documented by medical interview and by appropriate materials - e.g. passport, birth certificate, etc)

• Age 20 to 35 years (incl.)

• BMI 18.5 to 25 kg/m2 (incl.)

Exclusion criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator

• Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease judged clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)

• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders