HealthyPhase 1NCT01535638

Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 207127
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: Feb 2012to Mar 2012
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 21 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age =21and Age =50 years
Body mass index =18.5 and BMI = 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Who cannot join

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts

Show all 22Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least 10 half-lifes prior to administration of the trial drug or during the trial
Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Alcohol abuse (more than 40 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
Excessive physical activities (within one week prior to first administration of the trial drug or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
History of photosensitivity or recurrent rash
Subject is not willing to avoid sun exposure from the first administration of the trial drug until the end of the study.

Trial locations and contacts

1 site in 1 country.

Germany1 site

1241.26.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Relative Bioavailability of BI 207127 FF Tablets, BI 207127 FF Modified Tablets and BI 207127 TFII Tablets Administered Orally as Three Tablets (Single Dose) to Healthy Male Volunteers, an Open-label, Randomised Three-way Crossover Study

The primary objective of the current study is to investigate the relative bioavailability of three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy volunteers, with the aim to compare the bioavailability of the three formulations. All treatments will be applied fed, 30 minutes after start of the intake of a standard normal breakfast.

Conditions: Healthy
Being tested: BI 207127

What participants receive

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

BI 207127Drug
Medium dose film-coated tablet
BI 207127Drug
Medium dose film-coated tablet
BI 207127Drug
Medium dose film-coated tablet

Study groups in NCT01535638
Study group	Role	What they receive
BI 207127 NA TFII medium dose	Active comparator	Film-coated tablet for oral administration Receives: Drug: BI 207127
BI 207127 NA FF medium dose	Active comparator	Film-coated tablet for oral administration Receives: Drug: BI 207127
BI 207127 NA FF modified medium dose	Active comparator	Film-coated tablet for oral administration Receives: Drug: BI 207127

What is being measured

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

AUC0-∞
Area under the concentration-time curve of Deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration
Cmax
Maximum measured concentration of Deleobuvir in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration

Timeline

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

Feb 2012Mar 2012

First posted20 Feb 2012 (estimated)
Study startFeb 2012
Primary completionMar 2012

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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01535638
Sponsor's protocol ID: 1241.26
Status last verified: Mar 2016
First submitted: 15 Feb 2012
Last updated: 11 Apr 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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of BI 207127 FF Tablets, BI 207127 FF Modified Tablets and BI 207127 TFII Tablets Administered Orally as Three Tablets (Single Dose) to Healthy Male Volunteers, an Open-label, Randomised Three-way Crossover Study
ClinicalTrials.gov ID: NCT01535638
Acronym / sponsor ID: 1241.26
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Mar 2012 (actual)
First posted: 20 Feb 2012 (estimated)
Results: Posted 11 Apr 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: 3

Arm	Type	Receives
BI 207127 NA TFII medium dose	Active comparator	Drug: BI 207127Film-coated tablet for oral administration
BI 207127 NA FF medium dose	Active comparator	Drug: BI 207127Film-coated tablet for oral administration
BI 207127 NA FF modified medium dose	Active comparator	Drug: BI 207127Film-coated tablet for oral administration

Who may qualify

Ages: 21 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age =21and Age =50 years
Body mass index =18.5 and BMI = 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Key exclusion criteria (22 listed)

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 207127Medium dose film-coated tablet	Drug	BI 207127 NA FF modified medium dose
BI 207127Medium dose film-coated tablet	Drug	BI 207127 NA FF medium dose
BI 207127Medium dose film-coated tablet	Drug	BI 207127 NA TFII medium dose

Primary outcome

AUC0-∞
Time frame: 1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration
Area under the concentration-time curve of Deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax
Time frame: 1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration
Maximum measured concentration of Deleobuvir in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Results and safety

Results posted to the registry on 11 Apr 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
Trial Formulation II / Final Formulation (FF) / FF Modified	3	3
Trial Formulation II / Final Formulation (FF) Modified / FF	3	3
Final Formulation (FF) / Trial Formulation II / FF Modified	3	3
Final Formulation (FF) / FF Modified / Trial Formulation II	3	3
Final Formulation (FF) Modified / Trial Formulation II / FF	3	3
Final Formulation (FF) Modified / FF / Trial Formulation II	3	2

Primary outcome: AUC0-∞

Time frame: 1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Deleobuvir Trial Formulation II n = 13	Deleobuvir Final Formulation n = 15	Deleobuvir Final Formulation Modified n = 14
Value	10600 (45.0)	12400 (57.3)	13600 (66.0)

Deleobuvir Trial Formulation II vs Deleobuvir Final Formulation: Ratio (%): 123.4 (90% CI 108.0 to 141.1)
Deleobuvir Final Formulation vs Deleobuvir Final Formulation Modified: Ratio (%): 109.8 (90% CI 88.6 to 136.1)

Population analysed: The pharmacokinetic set (PKS) included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK and no vomiting must have occurred at or before two times the median tmax.

Primary outcome: Cmax

Time frame: 1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Deleobuvir Trial Formulation II n = 13	Deleobuvir Final Formulation n = 15	Deleobuvir Final Formulation Modified n = 14
Value	2460 (48.3)	2990 (53.6)	3070 (73.1)

Deleobuvir Trial Formulation II vs Deleobuvir Final Formulation: Ratio (%): 122.5 (90% CI 107.9 to 139.1)
Deleobuvir Final Formulation vs Deleobuvir Final Formulation Modified: Ratio (%): 107.6 (90% CI 83.1 to 139.4)

Population analysed: The pharmacokinetic set (PKS).

Adverse events

Time frame: Adverse events (AE) occurring up to 2 days (48 h) after single intake of Deleobuvir tablets were assigned to the respective treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deleobuvir Trial Formulation II	0 of 16 (0%)	4 of 16 (25%)	Not reported
Deleobuvir Final Formulation	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Deleobuvir Final Formulation Modified	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
Deleobuvir (Total)	0 of 18 (0%)	7 of 18 (38.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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 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 4 inclusion and 22 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: finished, as of the sponsor's last update on 11 Apr 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 11 Apr 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?

AUC0-∞ (time frame: 1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h 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 NCT01535638.

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 11 Apr 2016.