HealthyPhase 1NCT04926246
A Study in Healthy Men to Find the Best Formulation of BI 685509 and to Test How it is Taken up in the Body
A Phase 1 study testing R1: Reference Product X, T1: Test Product M and T2: Test Product N in people with Healthy, run by Boehringer Ingelheim at 1 site in United Kingdom.
Trial summary
The main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- R1: Reference Product X, T1: Test Product M and T2: Test Product N
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 7 Feb 2022
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects according to the assessment of the investigator, as based on 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 of 18 to 55 years (inclusive) at the time of signing informed consent
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) at the time of signing informed consent
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Subjects who are sexually active must use with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:
- Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
Show all 11Show fewer
- Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
- Condoms plus surgically sterilised partner (including hysterectomy) or
- Condoms plus intrauterine device or
- Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner (both, male and female) to the study drug via seminal fluid. Male subjects should use a condom throughout the study and for 30 days after last Investigational Medicinal Product (IMP) administration. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active with their partner, they must comply with the contraceptive requirements detailed above.
- Male subjects should not donate sperm for the duration of the study and for at least 30 days after last IMP administration.
Who cannot join
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator, including not resolved post-vaccination reactions
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair, unless within the last 12 months)
- 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 Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Formulation Selection and Subsequent Optimization of Oral Formulations of BI 685509 in Healthy Male Subjects (Open-label, Randomized, Single-dose Design Study in up to Three Parts; Trial Part 1: Five-period Crossover; Optional Trial Parts 2 & 3: Fourperiod Crossover)
The main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed.
- Conditions
- Healthy
- Being tested
- R1: Reference Product X, T1: Test Product M, T2: Test Product N, T3: Test Product O, T4: Test Product O
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R1: Reference Product XDrug
under fasted conditions
T1: Test Product MDrug
under fasted conditions
T2: Test Product NDrug
under fasted conditions
T3: Test Product ODrug
under fasted conditions
T4: Test Product ODrug
under fed conditions
R2: Reference Product YDrug
under fasted conditions
T5: Test Product PDrug
under fasted conditions
T6: Test Product PDrug
under fed conditions
T7: Test Product QDrug
under fasted conditions
R3: Reference Product ZDrug
under fasted conditions
T8: Test Product SDrug
under fasted conditions
T9: Test Product SDrug
under fed conditions
T10: Test Product UDrug
under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Part 1: R1-T2-T4-T1-T3 | Experimental | Not described Receives: Drug: R1: Reference Product X; Drug: T1: Test Product M; Drug: T2: Test Product N; Drug: T3: Test Product O; Drug: T4: Test Product O |
| Part 1: T1-T4-T2-T3-R1 | Experimental | Not described Receives: Drug: R1: Reference Product X; Drug: T1: Test Product M; Drug: T2: Test Product N; Drug: T3: Test Product O; Drug: T4: Test Product O |
| Part 1: T2-T1-T3-R1-T4 | Experimental | Not described Receives: Drug: R1: Reference Product X; Drug: T1: Test Product M; Drug: T2: Test Product N; Drug: T3: Test Product O; Drug: T4: Test Product O |
| Part 1: T3-R1-T1-T4-T2 | Experimental | Not described Receives: Drug: R1: Reference Product X; Drug: T1: Test Product M; Drug: T2: Test Product N; Drug: T3: Test Product O; Drug: T4: Test Product O |
| Part 1: T4-T3-R1-T2-T1 | Experimental | Not described Receives: Drug: R1: Reference Product X; Drug: T1: Test Product M; Drug: T2: Test Product N; Drug: T3: Test Product O; Drug: T4: Test Product O |
| Part 2: R2-T7-T6-T5 | Experimental | Not described Receives: Drug: R2: Reference Product Y; Drug: T5: Test Product P; Drug: T6: Test Product P; Drug: T7: Test Product Q |
| Part 2: T5-T6-T7-R2 | Experimental | Not described Receives: Drug: R2: Reference Product Y; Drug: T5: Test Product P; Drug: T6: Test Product P; Drug: T7: Test Product Q |
| Part 2: T6-T5-R2-T7 | Experimental | Not described Receives: Drug: R2: Reference Product Y; Drug: T5: Test Product P; Drug: T6: Test Product P; Drug: T7: Test Product Q |
| Part 2: T7-R2-T5-T6 | Experimental | Not described Receives: Drug: R2: Reference Product Y; Drug: T5: Test Product P; Drug: T6: Test Product P; Drug: T7: Test Product Q |
| Part 3: R3-T10-T9-T8 | Experimental | Not described Receives: Drug: R3: Reference Product Z; Drug: T8: Test Product S; Drug: T9: Test Product S; Drug: T10: Test Product U |
| Part 3: T8-T9-T10-R3 | Experimental | Not described Receives: Drug: R3: Reference Product Z; Drug: T8: Test Product S; Drug: T9: Test Product S; Drug: T10: Test Product U |
| Part 3: T9-T8-R3-T10 | Experimental | Not described Receives: Drug: R3: Reference Product Z; Drug: T8: Test Product S; Drug: T9: Test Product S; Drug: T10: Test Product U |
| Part 3: T10-R3-T8-T9 | Experimental | Not described Receives: Drug: R3: Reference Product Z; Drug: T8: Test Product S; Drug: T9: Test Product S; Drug: T10: Test Product U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 5 days
Secondary outcomes (1)
Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jul 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
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
- Model description
- Study in up to three parts: Trial part 1: five-period crossover Optional trial part 2: four-period crossover Optional trial part 3: four-period crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926246
- Sponsor's protocol ID
- 1366-0024
- Status last verified
- Dec 2022
- First submitted
- 14 Jun 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation Selection and Subsequent Optimization of Oral Formulations of BI 685509 in Healthy Male Subjects (Open-label, Randomized, Single-dose Design Study in up to Three Parts; Trial Part 1: Five-period Crossover; Optional Trial Parts 2 & 3: Fourperiod Crossover)
- ClinicalTrials.gov ID
- NCT04926246
- Acronym / sponsor ID
- 1366-0024
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 15 Jun 2021 (actual)
- 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 main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 13
- Model description
- Study in up to three parts: Trial part 1: five-period crossover Optional trial part 2: four-period crossover Optional trial part 3: four-period crossover
| Arm | Type | Receives |
|---|---|---|
| Part 1: R1-T2-T4-T1-T3 | Experimental | Drug: R1: Reference Product X, Drug: T1: Test Product M, Drug: T2: Test Product N, Drug: T3: Test Product O, Drug: T4: Test Product O |
| Part 1: T1-T4-T2-T3-R1 | Experimental | Drug: R1: Reference Product X, Drug: T1: Test Product M, Drug: T2: Test Product N, Drug: T3: Test Product O, Drug: T4: Test Product O |
| Part 1: T2-T1-T3-R1-T4 | Experimental | Drug: R1: Reference Product X, Drug: T1: Test Product M, Drug: T2: Test Product N, Drug: T3: Test Product O, Drug: T4: Test Product O |
| Part 1: T3-R1-T1-T4-T2 | Experimental | Drug: R1: Reference Product X, Drug: T1: Test Product M, Drug: T2: Test Product N, Drug: T3: Test Product O, Drug: T4: Test Product O |
| Part 1: T4-T3-R1-T2-T1 | Experimental | Drug: R1: Reference Product X, Drug: T1: Test Product M, Drug: T2: Test Product N, Drug: T3: Test Product O, Drug: T4: Test Product O |
| Part 2: R2-T7-T6-T5 | Experimental | Drug: R2: Reference Product Y, Drug: T5: Test Product P, Drug: T6: Test Product P, Drug: T7: Test Product Q |
| Part 2: T5-T6-T7-R2 | Experimental | Drug: R2: Reference Product Y, Drug: T5: Test Product P, Drug: T6: Test Product P, Drug: T7: Test Product Q |
| Part 2: T6-T5-R2-T7 | Experimental | Drug: R2: Reference Product Y, Drug: T5: Test Product P, Drug: T6: Test Product P, Drug: T7: Test Product Q |
| Part 2: T7-R2-T5-T6 | Experimental | Drug: R2: Reference Product Y, Drug: T5: Test Product P, Drug: T6: Test Product P, Drug: T7: Test Product Q |
| Part 3: R3-T10-T9-T8 | Experimental | Drug: R3: Reference Product Z, Drug: T8: Test Product S, Drug: T9: Test Product S, Drug: T10: Test Product U |
| Part 3: T8-T9-T10-R3 | Experimental | Drug: R3: Reference Product Z, Drug: T8: Test Product S, Drug: T9: Test Product S, Drug: T10: Test Product U |
| Part 3: T9-T8-R3-T10 | Experimental | Drug: R3: Reference Product Z, Drug: T8: Test Product S, Drug: T9: Test Product S, Drug: T10: Test Product U |
| Part 3: T10-R3-T8-T9 | Experimental | Drug: R3: Reference Product Z, Drug: T8: Test Product S, Drug: T9: Test Product S, Drug: T10: Test Product U |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male subjects according to the assessment of the investigator, as based on 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 of 18 to 55 years (inclusive) at the time of signing informed consent
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) at the time of signing informed consent
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Subjects who are sexually active must use with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator, including not resolved post-vaccination reactions
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological 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 |
|---|---|---|
| R1: Reference Product Xunder fasted conditions | Drug | Part 1: R1-T2-T4-T1-T3, Part 1: T1-T4-T2-T3-R1, Part 1: T2-T1-T3-R1-T4, Part 1: T3-R1-T1-T4-T2, Part 1: T4-T3-R1-T2-T1 |
| T1: Test Product Munder fasted conditions | Drug | Part 1: R1-T2-T4-T1-T3, Part 1: T1-T4-T2-T3-R1, Part 1: T2-T1-T3-R1-T4, Part 1: T3-R1-T1-T4-T2, Part 1: T4-T3-R1-T2-T1 |
| T2: Test Product Nunder fasted conditions | Drug | Part 1: R1-T2-T4-T1-T3, Part 1: T1-T4-T2-T3-R1, Part 1: T2-T1-T3-R1-T4, Part 1: T3-R1-T1-T4-T2, Part 1: T4-T3-R1-T2-T1 |
| T3: Test Product Ounder fasted conditions | Drug | Part 1: R1-T2-T4-T1-T3, Part 1: T1-T4-T2-T3-R1, Part 1: T2-T1-T3-R1-T4, Part 1: T3-R1-T1-T4-T2, Part 1: T4-T3-R1-T2-T1 |
| T4: Test Product Ounder fed conditions | Drug | Part 1: R1-T2-T4-T1-T3, Part 1: T1-T4-T2-T3-R1, Part 1: T2-T1-T3-R1-T4, Part 1: T3-R1-T1-T4-T2, Part 1: T4-T3-R1-T2-T1 |
| R2: Reference Product Yunder fasted conditions | Drug | Part 2: R2-T7-T6-T5, Part 2: T5-T6-T7-R2, Part 2: T6-T5-R2-T7, Part 2: T7-R2-T5-T6 |
| T5: Test Product Punder fasted conditions | Drug | Part 2: R2-T7-T6-T5, Part 2: T5-T6-T7-R2, Part 2: T6-T5-R2-T7, Part 2: T7-R2-T5-T6 |
| T6: Test Product Punder fed conditions | Drug | Part 2: R2-T7-T6-T5, Part 2: T5-T6-T7-R2, Part 2: T6-T5-R2-T7, Part 2: T7-R2-T5-T6 |
| T7: Test Product Qunder fasted conditions | Drug | Part 2: R2-T7-T6-T5, Part 2: T5-T6-T7-R2, Part 2: T6-T5-R2-T7, Part 2: T7-R2-T5-T6 |
| R3: Reference Product Zunder fasted conditions | Drug | Part 3: R3-T10-T9-T8, Part 3: T10-R3-T8-T9, Part 3: T8-T9-T10-R3, Part 3: T9-T8-R3-T10 |
| T8: Test Product Sunder fasted conditions | Drug | Part 3: R3-T10-T9-T8, Part 3: T10-R3-T8-T9, Part 3: T8-T9-T10-R3, Part 3: T9-T8-R3-T10 |
| T9: Test Product Sunder fed conditions | Drug | Part 3: R3-T10-T9-T8, Part 3: T10-R3-T8-T9, Part 3: T8-T9-T10-R3, Part 3: T9-T8-R3-T10 |
| T10: Test Product Uunder fasted conditions | Drug | Part 3: R3-T10-T9-T8, Part 3: T10-R3-T8-T9, Part 3: T8-T9-T10-R3, Part 3: T9-T8-R3-T10 |
Primary outcome
Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 5 days
1 secondary outcome
Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 5 days
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 9 Dec 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 R1: Reference Product X, T1: Test Product M and T2: Test Product N in people with Healthy, run by Boehringer Ingelheim at 1 site in United Kingdom.
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 11 inclusion and 8 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 9 Dec 2022. 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 United Kingdom. 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?
Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: up to 5 days). 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 9 Dec 2022.