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

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ClinicalTrials.gov Identifier: NCT01983566
Recruitment Status : Terminated
First Posted : November 14, 2013
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 207127 high fat Drug: BI 207127 with Omeprazole Drug: BI 207127 Drug: BI 207127 low fat Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BI 207127 fasted
patient to receive BI 207127 as a single dose in fasted state
 Drug: BI 207127
BI 207127 as a single dose in fasted state
Experimental: BI 207127 high fat
patient to receive BI 207127 as a single dose after a high fat breakfast
 Drug: BI 207127 high fat
BI 207127 as a single dose after a high fat breakfast
Experimental: BI 207127 low fat
patient to receive BI 207127 as a single dose after a low fat breakfast
 Drug: BI 207127 low fat
BI 207127 as a single dose after a low fat breakfast
Experimental: BI 207127 with Omeprazole
patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day
 Drug: BI 207127 with Omeprazole
BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day


Outcome Measures
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Primary Outcome Measures :
  1. AUC(0-tz) [ Time Frame: 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 ]
    Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  2. Cmax [ Time Frame: 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 ]
    Maximum measured concentration of deleobuvir in plasma (Cmax)


Secondary Outcome Measures :
  1. AUC(0-inf) [ Time Frame: 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 ]
    Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983566


Locations
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Germany
1241.44.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01983566    
Other Study ID Numbers: 1241.44
2013-003967-74 ( EudraCT Number: EudraCT )
First Posted: November 14, 2013    Key Record Dates
Results First Posted: May 16, 2016
Last Update Posted: May 16, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action