Adults 20 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Drug-related Adverse EventsPrimary· From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days.
The percentage of participants treated with investigational drug who experience such an event.
Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported.
Percentages are calculated using total number of participants per treatment as the denominator.
Group
Value
95% CI
Placebo Matching BI 706321 (Part I)
8.3
2 mg BI 706321 (Part I)
11.1
5 mg BI 706321 (Part I)
44.4
8 mg BI 706321 (Part I)
66.7
10 mg BI 706321 (Part I)
88.9
Single-Dose Part: Area Under the Concentration-time Curve of the BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUCR0-∞)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
The area under the concentration-time curve of the BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUCR0-∞) after the first dose administration is reported.
Group
Value
95% CI
2 mg BI 706321 (Part I - Single-Dose Part Only)
78.0
± 31.8
5 mg BI 706321 (Part I - Single-Dose Part Only)
196
± 28.7
8 mg BI 706321 (Part I)
447
± 32.9
10 mg BI 706321 (Part I - Single-Dose Part Only)
393
± 25.7
Single-Dose Part: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
The maximum measured concentration of BI 706321 in plasma (Cmax) after the first dose administration is reported.
Group
Value
95% CI
2 mg BI 706321 (Part I - Single-Dose Part Only)
3.00
± 30.6
5 mg BI 706321 (Part I - Single-Dose Part Only)
8.20
± 47.9
8 mg BI 706321 (Part I)
18.4
± 35.4
10 mg BI 706321 (Part I - Single-Dose Part Only)
17.7
± 36.4
Single-Dose Part: Time From Dosing to Maximum Measured Concentration of BI 706321 in PlasmaSecondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
The time from dosing to maximum measured concentration of BI 706321 in plasma after first drug administration is reported.
Group
Value
95% CI
2 mg BI 706321 (Part I - Single-Dose Part Only)
5.00
2.00 – 5.00
5 mg BI 706321 (Part I - Single-Dose Part Only)
5.00
2.00 – 5.00
8 mg BI 706321 (Part I)
5.00
2.00 – 5.00
10 mg BI 706321 (Part I - Single-Dose Part Only)
5.00
2.00 – 6.00
Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after single and multiple dose administration is reported.
Group
Value
95% CI
2 mg BI 706321 (Part I)
144
± 44.8
5 mg BI 706321 (Part I)
297
± 21.9
8 mg BI 706321 (Part I)
764
± 19.3
10 mg BI 706321 (Part I)
641
± 23.0
Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after single and multiple dose administration is reported
Group
Value
95% CI
2 mg BI 706321 (Part I)
7.30
± 55.4
5 mg BI 706321 (Part I)
20.0
± 25.7
8 mg BI 706321 (Part I)
52.4
± 11.1
10 mg BI 706321 (Part I)
43.3
± 24.5
Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after single and multiple dose administration is reported.
Group
Value
95% CI
2 mg BI 706321 (Part I)
3.47
± 39.0
5 mg BI 706321 (Part I)
7.88
± 31.9
8 mg BI 706321 (Part I)
20.8
± 27.0
10 mg BI 706321 (Part I)
17.4
± 25.1
Accumulation Ratio Based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
The accumulation ratio based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) shows how much the drug concentration increases at steady state compared to the first dose. It is calculated as a ratio of Cₘₐₓ at steady state (Cₘₐₓ,ₛₛ) and Cₘₐₓ after the first dose (Cₘₐₓ).
Rᴀ,ᴄₘₐₓ,ₛₛ = Cₘₐₓₛₛ/Cₘₐₓ.
Group
Value
95% CI
2 mg BI 706321 (Part I)
2.43
± 34.5
5 mg BI 706321 (Part I)
2.44
± 25.2
8 mg BI 706321 (Part I)
2.85
± 36.2
10 mg BI 706321 (Part I)
2.44
± 23.1
Accumulation Ratio Based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ)Secondary· Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
The accumulation ratio based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) shows how much the total drug exposure over a uniform dosing interval τ increases at steady state compared to the first dose. It is calculated as a ration of AUC₀-ₜ at steady state (AUC₀-ₜₛₛ) and AUC₀-ₜ after the first dose (AUC₀-ₜ).
Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ = AUC₀-ₜₛₛ/AUC₀-ₜ.
Group
Value
95% CI
2 mg BI 706321 (Part I)
3.03
± 29.1
5 mg BI 706321 (Part I)
3.00
± 23.2
8 mg BI 706321 (Part I)
3.52
± 31.0
10 mg BI 706321 (Part I)
3.12
± 18.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses.
Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 23 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05183360.