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CompletedNCT04426851Updated Mar 30, 2025Results posted

A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood

A Phase 1 interventional study of BI 1358894 and BI 1358894 (C-14) intravenous solution in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894 and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.

The main objective of Part 2 of this trial is to investigate the relative bioavailability of BI 1358894 administered as an oral suspension.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male subjects according to the assessment of the investigator, as 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 55 years (inclusive)
  • BMI of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
  • Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 90 days after trial completion:
  • Use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or,
  • Sexually abstinent or
  • A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or
  • Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy) or
  • Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH (follicle stimulating hormone) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria

Exclusion Criteria:

  • 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 40 to 100 bpm
  • C-reactive protein (CRP) > upper limit of normal (ULN), liver or kidney parameter above ULN
  • 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
  • Further exclusion criteria apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    BI 1358894: Part 1: tablet (T1) - (C14) i.v (R1), Part 2: fasted (R2) - fed (T2)

    BI 1358894

    Drug: BI 1358894 · Drug: BI 1358894 (C-14) intravenous solution

  • Experimental
    BI 1358894: Part 1: tablet (T1) - (C14) i.v (R1), Part 2: fed (T2) - fasted (R2)

    BI 1358894

    Drug: BI 1358894 · Drug: BI 1358894 (C-14) intravenous solution

Interventions

  • DrugBI 1358894

    Tablet

  • DrugBI 1358894 (C-14) intravenous solution

    BI 1358894 mixed with \[carbon labelled (C-14)\] BI 1358894

  • DrugBI 1358894

    Oral suspension

06

What researchers measure

Primary outcomes

  1. Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity)

    Area under the concentration-time curve of BI 1358894 over the time interval from 0 to infinity after i.v. administration and after oral administration (AUC0-infinity) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. Standard error is actually geometric standard error. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.

    Time frame: Within 2 hours (h) before and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.

  2. Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312)

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 312 h (AUC 0-312) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.

    Time frame: Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.

Secondary outcomes

  1. Part 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax)

    Maximum measured concentration of BI 1358894 in plasma after i.v. administration and after oral administration(Cmax) is reported. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.

    Time frame: Within 2 hours before and at 15 minutes (min), 30 min, 1 hour (h), 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.

  2. Part 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax)

    Maximum measured concentration of BI 1358894 in plasma after administration of the oral suspension (Cmax) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.

    Time frame: Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.

  3. Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity)

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity after administration of the oral suspension (AUC0-infinity) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.

    Time frame: Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.

07

Results

Posted Mar 30, 2025

Participant flow

This was a phase I trial which investigated the pharmacokinetics and absolute bioavailability of BI 1358894 administered orally as tablet co-administered with an intravenous microtracer dose of labelled \[C-14\]-BI 1358894 in healthy male volunteers via a non-randomised, open-label, fixed-sequence trial (part 1) followed by a randomised, openlabel, single-dose, two-period, two-sequence cross-over relative bioavailability trial in BI 1358894 oral suspension (part 2).

Part 1: Period 1+Washout
Participant flow — Part 1: Period 1+Washout
MilestoneBI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)
Started66
Completed66
Not completed00
Part 2: Period 2+Washout
Participant flow — Part 2: Period 2+Washout
MilestoneBI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)
Started66
Completed55
Not completed11
Withdrew: Withdrawal by subject01
Withdrew: Adverse event10
Part 2: Period 3+Washout
Participant flow — Part 2: Period 3+Washout
MilestoneBI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)
Started55
Completed55
Not completed00

Outcome measures

PrimaryPart 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity)

Area under the concentration-time curve of BI 1358894 over the time interval from 0 to infinity after i.v. administration and after oral administration (AUC0-infinity) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. Standard error is actually geometric standard error. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.

Time frame:
Within 2 hours (h) before and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.
Reported as:
Geometric least squares mean · hour*millimol/Liter/kilogram
Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity)
hour*millimol/Liter/kilogramBI 1358894 100 mg Tablet FastedBI 1358894 (C-14) 100 ug i.v
Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity)96 ± NA209 ± NA
Statistical analysis
  • BI 1358894 100 mg Tablet Fasted vs BI 1358894 (C-14) 100 ug i.v · Ratio of the geometric means (%): 45.9 · 90% CI 41.4 to 50.9Ratio was calculated as: BI 1358894 100 mg tablet fasted/BI 1358894 (C-14) 100 ug i.v. Intra-individual geometric coefficient of variation (gCV)=14.3.
PrimaryPart 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312)

Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 312 h (AUC 0-312) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.

Time frame:
Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.
Reported as:
Geometric least squares mean · hour* nanomol/Liter (h*nmol/L)
Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312)
hour* nanomol/Liter (h*nmol/L)BI 1358894 100 mg Oral Suspension FastedBI 1358894 100 mg Oral Suspension Fed
Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312)12217 ± NA17271 ± NA
Statistical analysis
  • BI 1358894 100 mg Oral Suspension Fasted vs BI 1358894 100 mg Oral Suspension Fed · Ratio of the geometric means (%): 141.4 · 90% CI 129.3 to 154.6Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra -individual geometric coefficient of variation (gCV)=10.9.
SecondaryPart 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax)

Maximum measured concentration of BI 1358894 in plasma after i.v. administration and after oral administration(Cmax) is reported. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.

Time frame:
Within 2 hours before and at 15 minutes (min), 30 min, 1 hour (h), 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.
Reported as:
Geometric mean · nanomol/Liter (nmol/L)
Part 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax)
nanomol/Liter (nmol/L)BI 1358894 100 mg Tablet FastedBI 1358894 (C-14) 100 ug i.v
Part 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax)408 ± 34.10.847 ± 28.8
SecondaryPart 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax)

Maximum measured concentration of BI 1358894 in plasma after administration of the oral suspension (Cmax) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.

Time frame:
Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.
Reported as:
Geometric least squares mean · nanomol/Liter (nmol/L)
Part 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax)
nanomol/Liter (nmol/L)BI 1358894 100 mg Oral Suspension FastedBI 1358894 100 mg Oral Suspension Fed
Part 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax)810 ± NA529 ± NA
Statistical analysis
  • BI 1358894 100 mg Oral Suspension Fasted vs BI 1358894 100 mg Oral Suspension Fed · Ratio of the geometric means (%): 65.3 · 90% CI 54.6 to 78.0Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV)=22.5.
SecondaryPart 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity)

Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity after administration of the oral suspension (AUC0-infinity) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.

Time frame:
Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.
Reported as:
Geometric least squares mean · hour*nanomol/Liter (h*nmol/L)
Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity)
hour*nanomol/Liter (h*nmol/L)BI 1358894 100 mg Oral Suspension FastedBI 1358894 100 mg Oral Suspension Fed
Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity)13510 ± NA20052 ± NA
Statistical analysis
  • BI 1358894 100 mg Oral Suspension Fasted vs BI 1358894 100 mg Oral Suspension Fed · Ratio of the geometric means (%): 148.4 · 90% CI 138.1 to 159.5Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV) =8.7.

Adverse events

Collected over BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BI 1358894 100 mg Tablet Fasted0/12 (0%)0/12 (0%)6/12 (50%)
BI 1358894 (C-14) 100 ug i.v0/12 (0%)0/12 (0%)9/12 (75%)
BI 1358894 100 mg Oral Suspension Fasted0/11 (0%)0/11 (0%)6/11 (54.5%)
BI 1358894 100 mg Oral Suspension Fed0/11 (0%)0/11 (0%)8/11 (72.7%)
Most frequent other events
Showing 10 of 23
Most frequent other events
EventBI 1358894 100 mg Tablet FastedBI 1358894 (C-14) 100 ug i.vBI 1358894 100 mg Oral Suspension FastedBI 1358894 100 mg Oral Suspension Fed
HeadacheNervous system disorders5/125/125/117/11
SomnolenceNervous system disorders0/123/120/110/11
DizzinessNervous system disorders0/121/122/110/11
ErythemaSkin and subcutaneous tissue disorders0/122/120/111/11
Disturbance in attentionNervous system disorders0/120/120/111/11
DiarrhoeaGastrointestinal disorders0/121/121/110/11
FatigueGeneral disorders1/121/121/110/11
Skin exfoliationSkin and subcutaneous tissue disorders0/120/120/111/11
ArthralgiaMusculoskeletal and connective tissue disorders0/120/121/110/11
Back painMusculoskeletal and connective tissue disorders0/121/120/111/11

Baseline characteristics

Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.

Age, Continuous
Age, Continuous(Years)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)Total
Mean39.2 ± 11.937.8 ± 14.038.5 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)Total
Female000
Male6612
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)Total
Hispanic or Latino000
Not Hispanic or Latino6612
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White6612
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • ICON
    Groningen, 9728 NZ, Netherlands
09

References and documents

Related links

Study documents

  • Study protocol · Jun 26, 2020
  • Statistical analysis plan · Feb 9, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04426851
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Jul 13, 2020
Primary completion
Oct 12, 2020
Completion
Oct 12, 2020
Results posted
Mar 30, 2025
Last update
Mar 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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