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

NCT01983566 | Terminated Phase 1 Results

• 2 other identifiers: 1241.442013-003967-74
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC(0-tz)

  Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-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

• Cmax

  Maximum measured concentration of deleobuvir in plasma (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

Secondary Outcomes (1)

• 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

Study Arms (4)

BI 207127 fasted

ACTIVE COMPARATOR

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

Drug: BI 207127

BI 207127 high fat

EXPERIMENTAL

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

Drug: BI 207127 high fat

BI 207127 low fat

EXPERIMENTAL

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

Drug: BI 207127 low fat

BI 207127 with Omeprazole

EXPERIMENTAL

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

Interventions

BI 207127 high fat DRUG

BI 207127 as a single dose after a high fat breakfast

BI 207127 high fat

BI 207127 with Omeprazole DRUG

BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day

BI 207127 with Omeprazole

BI 207127 DRUG

BI 207127 as a single dose in fasted state

BI 207127 fasted

BI 207127 low fat DRUG

BI 207127 as a single dose after a low fat breakfast

BI 207127 low fat

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1241.44.49001 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

MeSH Terms

Interventions

deleobuvir; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

As the study was discontinued prematurely, the results were incomplete. Due to this incomplete data the endpoint AUC(0-inf) was not evaluated,and only a limited number of the planned statistical analyses could be performed.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 16, 2016
• Results First Posted: May 16, 2016

Record last verified: 2016-04

Locations

DE (1)