Clinical trial NCT01983566: Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects
Official title: Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of Deleobuvir Following Single Oral Administration in Healthy Caucasian and Japanese Subjects (an Open-label, Randomised, Four-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: AUC(0-tz)
timeFrame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
measure: Cmax
timeFrame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Secondary outcomes:
measure: AUC(0-inf)
timeFrame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 1241.44.49001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: