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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: BI 207127; Drug: BI 207127 low fat; Drug: BI 207127 with Omeprazole; Drug: BI 207127 high fat

• Registration Number: NCT01983566
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2016-01-21
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-12
• Last Update Submitted: 2016-04-12
• Results First Posted: 2016-05-16
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 207127 fasted	BI 207127	patient to receive BI 207127 as a single dose in fasted state
BI 207127 low fat	BI 207127 low fat	patient to receive BI 207127 as a single dose after a low fat breakfast
BI 207127 with Omeprazole	BI 207127 with Omeprazole	patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day
BI 207127 high fat	BI 207127 high fat	patient to receive BI 207127 as a single dose after a high fat breakfast

Primary Outcome Measures

Name	Time	Method
AUC(0-tz)	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)
Cmax	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

Name	Time	Method
AUC(0-inf)	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)

Trial Locations

Locations (1)

1241.44.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany