Trial Outcomes & Findings for A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men (NCT NCT06139302)
NCT ID: NCT06139302
Last Updated: 2025-12-01
Results Overview
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is reported.
COMPLETED
PHASE1
12 participants
Within 3 hours (hrs) before drug intake and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hrs after drug intake.
2025-12-01
Participant Flow
This was an open-label, non-randomized, and parallel group design study aimed to investigate pharmacokinetics of R-BI 1015550 (nerandomilast) in healthy Japanese male subjects following oral administrations of a single nerandomilast dose of 9 milligrams (mg) or 18 mg.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Nerandomilast 9 mg
Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Nerandomilast 18 mg
Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
Baseline characteristics by cohort
| Measure |
Nerandomilast 9 mg
n=6 Participants
Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Nerandomilast 18 mg
n=6 Participants
Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.8 Years
STANDARD_DEVIATION 10.1 • n=121 Participants
|
26.2 Years
STANDARD_DEVIATION 9.6 • n=122 Participants
|
29.0 Years
STANDARD_DEVIATION 9.9 • n=243 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before drug intake and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hrs after drug intake.Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS set included all subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is reported.
Outcome measures
| Measure |
Nerandomilast 9 mg
n=6 Participants
Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs).
|
Nerandomilast 18 mg
n=6 Participants
Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs).
|
|---|---|---|
|
Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
2070 hours*nanomoles/Liter (h*nmol/L)
Geometric Coefficient of Variation 13.8
|
3740 hours*nanomoles/Liter (h*nmol/L)
Geometric Coefficient of Variation 52.8
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before drug intake and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hrs after drug intake.Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS set included all subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration (Cmax) of nerandomilast in plasma is reported.
Outcome measures
| Measure |
Nerandomilast 9 mg
n=6 Participants
Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs).
|
Nerandomilast 18 mg
n=6 Participants
Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs).
|
|---|---|---|
|
Maximum Measured Concentration (Cmax) of Nerandomilast in Plasma
|
455 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 10.6
|
628 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 138
|
Adverse Events
Nerandomilast 9 mg
Nerandomilast 18 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nerandomilast 9 mg
n=6 participants at risk
Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs).
|
Nerandomilast 18 mg
n=6 participants at risk
Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Serious adverse events, other adverse events and all-cause mortality: From time of trial drug administration up to 7 days.
Adverse events were reported for the treated set (TS). The treated set included all subjects who were treated with at least one dose of nerandomilast. The treatment assignments were determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/6 • Serious adverse events, other adverse events and all-cause mortality: From time of trial drug administration up to 7 days.
Adverse events were reported for the treated set (TS). The treated set included all subjects who were treated with at least one dose of nerandomilast. The treatment assignments were determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER