HealthyPhase 1NCT02438696
Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects
A Phase 1 study testing BI 1060469, iFF, Test, BI 1060469, TF1, Reference and BI 1060469, TF2, Test in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1060469, iFF, Test, BI 1060469, TF1, Reference and BI 1060469, TF2, Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects according to the investigator¿s assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
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- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
- Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 20 g per day)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion
- Lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF) Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose) in Healthy Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study at Two Different Dose Strengths)
The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.
- Conditions
- Healthy
- Being tested
- BI 1060469, iFF, Test, BI 1060469, TF1, Reference, BI 1060469, TF2, Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1060469, iFF, TestDrug
BI 1060469, iFF, TestDrug
BI 1060469, TF1, ReferenceDrug
BI 1060469, TF2, TestDrug
BI 1060469, TF2, TestDrug
BI 1060469, iFF, TestDrug
BI 1060469, TF1, ReferenceDrug
BI 1060469, iFF, TestDrug
BI 1060469, iFF, TestDrug
BI 1060469, TF1, ReferenceDrug
BI 1060469, TF2, TestDrug
BI 1060469, TF1, ReferenceDrug
BI 1060469, TF1, ReferenceDrug
BI 1060469, TF2, TestDrug
BI 1060469, TF2, TestDrug
BI 1060469, iFF, TestDrug
BI 1060469, TF2, TestDrug
BI 1060469, TF1, ReferenceDrug
| Study group | Role | What they receive |
|---|---|---|
| 3 BI 1060469 low dose | Experimental | TF2 followed by iFF followed by TF1 Receives: Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test; Drug: BI 1060469, iFF, Test |
| 1 BI 1060469 high dose | Experimental | TF1 followed by TF2 followed by iFF Receives: Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test |
| 2 BI 1060469 high dose | Experimental | iFF followed by TF1 followed by TF2 Receives: Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF2, Test; Drug: BI 1060469, TF1, Reference |
| 3 BI 1060469 high dose | Experimental | TF2 followed by iFF followed by TF1 Receives: Drug: BI 1060469, TF2, Test; Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference |
| 1 BI 1060469 low dose | Experimental | TF1 followed by TF2 followed by iFF Receives: Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test |
| 2 BI 1060469 low dose | Experimental | iFF followed by TF1 followed by TF2 Receives: Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 h
Secondary outcomes (1)
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438696
- Sponsor's protocol ID
- 1333.4
- Other IDs
- 2014-005507-24, 2014
- Status last verified
- Sep 2015
- First submitted
- 6 May 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF) Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose) in Healthy Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study at Two Different Dose Strengths)
- ClinicalTrials.gov ID
- NCT02438696
- Acronym / sponsor ID
- 1333.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 3 BI 1060469 low dose | Experimental | Drug: BI 1060469, TF1, Reference, Drug: BI 1060469, TF2, Test, Drug: BI 1060469, iFF, TestTF2 followed by iFF followed by TF1 |
| 1 BI 1060469 high dose | Experimental | Drug: BI 1060469, iFF, Test, Drug: BI 1060469, TF1, Reference, Drug: BI 1060469, TF2, TestTF1 followed by TF2 followed by iFF |
| 2 BI 1060469 high dose | Experimental | Drug: BI 1060469, iFF, Test, Drug: BI 1060469, TF2, Test, Drug: BI 1060469, TF1, ReferenceiFF followed by TF1 followed by TF2 |
| 3 BI 1060469 high dose | Experimental | Drug: BI 1060469, TF2, Test, Drug: BI 1060469, iFF, Test, Drug: BI 1060469, TF1, ReferenceTF2 followed by iFF followed by TF1 |
| 1 BI 1060469 low dose | Experimental | Drug: BI 1060469, iFF, Test, Drug: BI 1060469, TF1, Reference, Drug: BI 1060469, TF2, TestTF1 followed by TF2 followed by iFF |
| 2 BI 1060469 low dose | Experimental | Drug: BI 1060469, iFF, Test, Drug: BI 1060469, TF1, Reference, Drug: BI 1060469, TF2, TestiFF followed by TF1 followed by TF2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects according to the investigator¿s assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Key exclusion criteria (25 listed)
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as 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 1060469, iFF, Test | Drug | 2 BI 1060469 high dose |
| BI 1060469, iFF, Test | Drug | 1 BI 1060469 high dose |
| BI 1060469, TF1, Reference | Drug | 3 BI 1060469 low dose |
| BI 1060469, TF2, Test | Drug | 2 BI 1060469 high dose |
| BI 1060469, TF2, Test | Drug | 3 BI 1060469 high dose |
| BI 1060469, iFF, Test | Drug | 2 BI 1060469 low dose |
| BI 1060469, TF1, Reference | Drug | 1 BI 1060469 high dose |
| BI 1060469, iFF, Test | Drug | 3 BI 1060469 high dose |
| BI 1060469, iFF, Test | Drug | 1 BI 1060469 low dose |
| BI 1060469, TF1, Reference | Drug | 2 BI 1060469 low dose |
| BI 1060469, TF2, Test | Drug | 3 BI 1060469 low dose |
| BI 1060469, TF1, Reference | Drug | 2 BI 1060469 high dose |
| BI 1060469, TF1, Reference | Drug | 1 BI 1060469 low dose |
| BI 1060469, TF2, Test | Drug | 1 BI 1060469 high dose |
| BI 1060469, TF2, Test | Drug | 1 BI 1060469 low dose |
| BI 1060469, iFF, Test | Drug | 3 BI 1060469 low dose |
| BI 1060469, TF2, Test | Drug | 2 BI 1060469 low dose |
| BI 1060469, TF1, Reference | Drug | 3 BI 1060469 high dose |
Primary outcome
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
1 secondary outcome
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
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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 1060469, iFF, Test, BI 1060469, TF1, Reference and BI 1060469, TF2, Test 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 25 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 24 Sep 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) (time frame: up to 72 h). 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?
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 24 Sep 2015.