HealthyPhase 1NCT01983566

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

A Phase 1 study testing BI 207127 high fat, BI 207127 with Omeprazole and BI 207127 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 207127 high fat, BI 207127 with Omeprazole and BI 207127
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: Nov 2013to Jan 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.)

Who cannot join

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 locations and contacts

1 site in 1 country.

Germany1 site

1241.44.49001 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

About this study

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)

Conditions: Healthy
Being tested: BI 207127 high fat, BI 207127 with Omeprazole, BI 207127, BI 207127 low fat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 207127 high fatDrug
BI 207127 as a single dose after a high fat breakfast
BI 207127 with OmeprazoleDrug
BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day
BI 207127Drug
BI 207127 as a single dose in fasted state
BI 207127 low fatDrug
BI 207127 as a single dose after a low fat breakfast

Study groups in NCT01983566
Study group	Role	What they receive
BI 207127 fasted	Active comparator	patient to receive BI 207127 as a single dose in fasted state Receives: Drug: BI 207127
BI 207127 high fat	Experimental	patient to receive BI 207127 as a single dose after a high fat breakfast Receives: Drug: BI 207127 high fat
BI 207127 low fat	Experimental	patient to receive BI 207127 as a single dose after a low fat breakfast Receives: 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 Receives: Drug: BI 207127 with Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Jan 2014

First posted14 Nov 2013 (estimated)
Study startNov 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01983566
Sponsor's protocol ID: 1241.44
Other IDs: 2013-003967-74
Status last verified: Apr 2016
First submitted: 5 Nov 2013
Last updated: 16 May 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01983566
Acronym / sponsor ID: 1241.44
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 14 Nov 2013 (estimated)
Results: Posted 16 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
BI 207127 fasted	Active comparator	Drug: BI 207127patient to receive BI 207127 as a single dose in fasted state
BI 207127 high fat	Experimental	Drug: BI 207127 high fatpatient to receive BI 207127 as a single dose after a high fat breakfast
BI 207127 low fat	Experimental	Drug: BI 207127 low fatpatient to receive BI 207127 as a single dose after a low fat breakfast
BI 207127 with Omeprazole	Experimental	Drug: BI 207127 with Omeprazolepatient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day

Who may qualify

Ages: 20 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 207127 high fatBI 207127 as a single dose after a high fat breakfast	Drug	BI 207127 high fat
BI 207127 with OmeprazoleBI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day	Drug	BI 207127 with Omeprazole
BI 207127BI 207127 as a single dose in fasted state	Drug	BI 207127 fasted
BI 207127 low fatBI 207127 as a single dose after a low fat breakfast	Drug	BI 207127 low fat

Primary outcome

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)
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)

1 secondary outcome

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

Results and safety

Results posted to the registry on 16 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat	4	4
Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP	4	4
Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted	4	4
Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat	4	4

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Dele Fasted n = 11	Dele High Fat n = 10	Dele Low Fat n = 12	Dele + OMP n = 10
Value	9790 (60.2)	16900 (98.8)	14200 (46.8)	15800 (72.1)

Dele Fasted vs Dele Low Fat: Geometric mean ratio (%): 115.80 (90% CI 63.52 to 211.11), p = 0.3944, ANOVA

Population analysed: Pharmacokinetic set (PKS): included all subjects in the Treated Set who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint that was not affected by important protocol violations relevant to the evaluation of PK.

Primary outcome: Cmax

Measure	Dele Fasted n = 11	Dele High Fat n = 10	Dele Low Fat n = 12	Dele + OMP n = 10
Value	2140 (60.1)	3930 (92.5)	3160 (52.2)	3190 (90.2)

Dele Fasted vs Dele Low Fat: Geometric mean ratio (%): 114.83 (90% CI 74.803 to 176.281), p = 0.3674, ANOVA

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time of first administration of the respective treatment until start of the next treatment or until the day after the termination date (or until 3 days after administration of last study drug, whichever occurred later), up to 37 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dele Fasted	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Dele High Fat	0 of 10 (0%)	1 of 10 (10%)	Not reported
Dele Low Fat	0 of 12 (0%)	4 of 12 (33.3%)	Not reported
Dele + OMP	0 of 10 (0%)	7 of 10 (70%)	Not reported
OMP Alone	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Healthy

RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 207127 high fat, BI 207127 with Omeprazole and BI 207127 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01983566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.