HealthyPhase 1NCT05354453
A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0001)
A Phase 1 study testing BI 1839100 and allyl isothiocyanate (AITC) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
This trial starts the clinical development of BI 1839100. Effects of single rising doses of BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further development in patients with pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1839100 and allyl isothiocyanate (AITC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 May 2022to 14 Jun 2023
- 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 45 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 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Male subjects who meet any of the following criteria for a highly effective contraception from the first administration of trial medication until 90 days after trial completion:
- Willing to use a medically accepted method of contraception. Acceptable methods of contraception for use by male subjects include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, and barrier contraception (condom)
- Subjects who are not vasectomised or sexually abstinent have to ensure that an additional acceptable method of contraception (in addition to male condom) will be used by his female partner such as intrauterine device (IUD), surgical sterilisation (including hysterectomy), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 month prior to drug administration or postmenopausal status of female partner (defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed 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 45 to 90 bpm (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
- 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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)
- 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: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 1839100 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
This trial starts the clinical development of BI 1839100. Effects of single rising doses of BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further development in patients with pulmonary fibrosis.
- Conditions
- Healthy
- Being tested
- BI 1839100, Placebo, allyl isothiocyanate (AITC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1839100Drug
BI 1839100
PlaceboDrug
Placebo
allyl isothiocyanate (AITC)Drug
allyl isothiocyanate (AITC)
| Study group | Role | What they receive |
|---|---|---|
| SRD Part | Experimental | Single-rising dose (SRD) Receives: Drug: BI 1839100 |
| SRD Part: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Skin Challenge Part | Experimental | Not described Receives: Drug: BI 1839100; Drug: allyl isothiocyanate (AITC) |
| Skin Challenge Part: Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: allyl isothiocyanate (AITC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Measured: up to 10 days
Secondary outcomes (3)
Area under the concentration-time curve of BI 1839100 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 4 days
Maximum measured concentration of BI 1839100 in plasma (Cmax)
Measured: up to 4 days
Time from dosing to maximum measured concentration of BI 1839100 in plasma (tmax)
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start23 May 2022
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 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
- NCT05354453
- Sponsor's protocol ID
- 1490-0001
- Other IDs
- 2021-006294-27
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 1839100 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT05354453
- Acronym / sponsor ID
- 1490-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 29 Apr 2022 (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.
This trial starts the clinical development of BI 1839100. Effects of single rising doses of BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further development in patients with pulmonary fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SRD Part | Experimental | Drug: BI 1839100Single-rising dose (SRD) |
| SRD Part: Placebo | Placebo comparator | Drug: Placebo |
| Skin Challenge Part | Experimental | Drug: BI 1839100, Drug: allyl isothiocyanate (AITC) |
| Skin Challenge Part: Placebo | Placebo comparator | Drug: Placebo, Drug: allyl isothiocyanate (AITC) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Male subjects who meet any of the following criteria for a highly effective contraception from the first administration of trial medication until 90 days after trial completion:
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed 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 45 to 90 bpm (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
- 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
- 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 1839100BI 1839100 | Drug | SRD Part, Skin Challenge Part |
| PlaceboPlacebo | Drug | SRD Part: Placebo, Skin Challenge Part: Placebo |
| allyl isothiocyanate (AITC)allyl isothiocyanate (AITC) | Drug | Skin Challenge Part, Skin Challenge Part: Placebo |
Primary outcome
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to 10 days
3 secondary outcomes
Area under the concentration-time curve of BI 1839100 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 4 days
Maximum measured concentration of BI 1839100 in plasma (Cmax)
Time frame: up to 4 days
Time from dosing to maximum measured concentration of BI 1839100 in plasma (tmax)
Time frame: up to 4 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 3 Jul 2023.
- 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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 BI 1839100 and allyl isothiocyanate (AITC) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
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 7 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 3 Jul 2023. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator (time frame: up to 10 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 3 Jul 2023.