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

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: BI 207127 high fat; Drug: BI 207127 low fat; Drug: BI 207127; Drug: BI 207127 with Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01983566

1241.44

2013-003967-74 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

BI 207127 fasted

Active Comparator group

Description:

patient to receive BI 207127 as a single dose in fasted state

Treatment:

Drug: BI 207127

BI 207127 high fat

Experimental group

Description:

patient to receive BI 207127 as a single dose after a high fat breakfast

Treatment:

Drug: BI 207127 high fat

BI 207127 low fat

Experimental group

Description:

patient to receive BI 207127 as a single dose after a low fat breakfast

Treatment:

Drug: BI 207127 low fat

BI 207127 with Omeprazole

Experimental group

Description:

patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day

Treatment:

Drug: BI 207127 with Omeprazole