Trial Outcomes & Findings for A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood (NCT NCT03886272)
NCT ID: NCT03886272
Last Updated: 2023-07-17
Results Overview
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.
Results posted on
2023-07-17
Participant Flow
An open-label, single dose, randomized, 2-way and 3-way crossover trial in healthy subjects compared the relative bioavailability of intended commercial formulations (iCF) of BI 730357 to BI 730357 trial formulation 1 (TF1); and compared the bioavailability of different iCF batches (coarse-milled vs. unmilled vs. regularly milled).
Only subjects that met all the study inclusion and non of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
Participant milestones
| Measure |
50 mg BI 730357 iCF (T1) / 50 mg BI 730357 TF 1 (R1)
1 tablet of 50 milligram (mg) BI 730357 intended commercial formulations (iCF) final batch was administered as a single oral dose with 240 milliliter (mL) water as test treatment 1 (T1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1), administered as a single oral dose with 240 mL water as reference treatment 1 (R1) after an overnight fast of at least 10h.
|
50 mg BI 730357 TF1 (R1) / 50 mg 730357 iCF (T1)
1 tablet of 50 milligram (mg) BI 730357 tablet formulation (TF1) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 1 (R1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 intended commercial formulations (iCF) final batch, administered as a single oral dose with 240 mL of water at test treatment 1 (T1) after an overnight fast of at least 10h.
|
200 mg BI 730357 iCF (T2) / 200 mg BI 730357 TF1 (R2)
2 tablets of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch were administered as a single oral dose with 240 milliliter (mL) water as test treatment 2 (T2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 tablet formulation 1 (TF1), administered as single oral dose with 240 mL water as reference treatment 2 (R2) after an overnight fast of at least 10h.
|
200 mg BI 730357 TF1 (R2)/ 200 mg BI 730357 iCF (T2)
2 tablets of 100 milligram (mg) BI 730357 tablet formulation 1 (TF1) were administered as a single oral dose with 240 milliliter (mL) of water as reference treatment 2 (R2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 intended commercial formulation (iCF) final batch, administered as a single oral dose with 240 mL water as test treatment 2 (T2) after an overnight fast of at least 10h.
|
100 mg BI 730357 Regularly Milled (R3)/ Coarse-milled (T3c)/ Unmilled (T3u)
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch regularly milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 3 (R3) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h.
|
100 mg BI 730357 Coarse Milled (T3c) / Unmilled (T3u)/Regularly Milled (R3)
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3c (T3c) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single oral dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h.
|
100 mg BI 730357 Unmilled (T3u) /Regularly Milled (R3)/Coarse Milled (T3c)
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3u (T3u) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h.
|
|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
7
|
7
|
5
|
5
|
5
|
|
Period 1
COMPLETED
|
7
|
7
|
7
|
7
|
5
|
4
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
7
|
7
|
7
|
7
|
5
|
4
|
5
|
|
Period 2
COMPLETED
|
7
|
7
|
7
|
7
|
5
|
4
|
5
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
0
|
0
|
0
|
5
|
4
|
5
|
|
Period 3
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
4
|
5
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
50 mg BI 730357 iCF (T1) / 50 mg BI 730357 TF 1 (R1)
1 tablet of 50 milligram (mg) BI 730357 intended commercial formulations (iCF) final batch was administered as a single oral dose with 240 milliliter (mL) water as test treatment 1 (T1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1), administered as a single oral dose with 240 mL water as reference treatment 1 (R1) after an overnight fast of at least 10h.
|
50 mg BI 730357 TF1 (R1) / 50 mg 730357 iCF (T1)
1 tablet of 50 milligram (mg) BI 730357 tablet formulation (TF1) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 1 (R1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 intended commercial formulations (iCF) final batch, administered as a single oral dose with 240 mL of water at test treatment 1 (T1) after an overnight fast of at least 10h.
|
200 mg BI 730357 iCF (T2) / 200 mg BI 730357 TF1 (R2)
2 tablets of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch were administered as a single oral dose with 240 milliliter (mL) water as test treatment 2 (T2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 tablet formulation 1 (TF1), administered as single oral dose with 240 mL water as reference treatment 2 (R2) after an overnight fast of at least 10h.
|
200 mg BI 730357 TF1 (R2)/ 200 mg BI 730357 iCF (T2)
2 tablets of 100 milligram (mg) BI 730357 tablet formulation 1 (TF1) were administered as a single oral dose with 240 milliliter (mL) of water as reference treatment 2 (R2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 intended commercial formulation (iCF) final batch, administered as a single oral dose with 240 mL water as test treatment 2 (T2) after an overnight fast of at least 10h.
|
100 mg BI 730357 Regularly Milled (R3)/ Coarse-milled (T3c)/ Unmilled (T3u)
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch regularly milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 3 (R3) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h.
|
100 mg BI 730357 Coarse Milled (T3c) / Unmilled (T3u)/Regularly Milled (R3)
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3c (T3c) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single oral dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h.
|
100 mg BI 730357 Unmilled (T3u) /Regularly Milled (R3)/Coarse Milled (T3c)
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3u (T3u) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h.
|
|---|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood
Baseline characteristics by cohort
| Measure |
50 mg BI 730357 iCF (T1) / 50 mg BI 730357 TF 1 (R1)
n=7 Participants
1 tablet of 50 milligram (mg) BI 730357 intended commercial formulations (iCF) final batch was administered as a single oral dose with 240 milliliter (mL) water as test treatment 1 (T1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1), administered as a single oral dose with 240 mL water as reference treatment 1 (R1) after an overnight fast of at least 10h.
|
50 mg BI 730357 TF1 (R1) / 50 mg 730357 iCF (T1)
n=7 Participants
1 tablet of 50 milligram (mg) BI 730357 tablet formulation (TF1) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 1 (R1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 intended commercial formulations (iCF) final batch, administered as a single oral dose with 240 mL of water at test treatment 1 (T1) after an overnight fast of at least 10h.
|
200 mg BI 730357 iCF (T2) / 200 mg BI 730357 TF1 (R2)
n=7 Participants
2 tablets of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch were administered as a single oral dose with 240 milliliter (mL) water as test treatment 2 (T2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 tablet formulation 1 (TF1), administered as single oral dose with 240 mL water as reference treatment 2 (R2) after an overnight fast of at least 10h.
|
200 mg BI 730357 TF1 (R2)/ 200 mg BI 730357 iCF (T2)
n=7 Participants
2 tablets of 100 milligram (mg) BI 730357 tablet formulation 1 (TF1) were administered as a single oral dose with 240 milliliter (mL) of water as reference treatment 2 (R2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 intended commercial formulation (iCF) final batch, administered as a single oral dose with 240 mL water as test treatment 2 (T2) after an overnight fast of at least 10h.
|
100 mg BI 730357 Regularly Milled (R3)/ Coarse-milled (T3c)/ Unmilled (T3u)
n=5 Participants
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch regularly milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 3 (R3) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h.
|
100 mg BI 730357 Coarse Milled (T3c) / Unmilled (T3u)/Regularly Milled (R3)
n=5 Participants
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3c (T3c) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single oral dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h.
|
100 mg BI 730357 Unmilled (T3u) /Regularly Milled (R3)/Coarse Milled (T3c)
n=5 Participants
1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3u (T3u) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.4 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
36.6 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
35.0 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
29.3 Years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
39.2 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
26.0 Years
STANDARD_DEVIATION 7.0 • n=10 Participants
|
29.6 Years
STANDARD_DEVIATION 4.6 • n=115 Participants
|
33.5 Years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
41 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
43 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint that was not excluded due to a protocol deviation or due to PK non-evaluability. It was sufficient for each subject to contribute only 1 PK parameter value for 1 period.
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
50 mg BI 730357 iCF (T1)
n=14 Participants
1 tablet of 50 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 1 (T1).
|
50 mg BI 730357 TF1 (R1)
n=14 Participants
1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 1 (R1).
|
200 mg BI 730357 iCF (T2)
n=14 Participants
2 tablets of 100 mg BI 730357 intended commercial formulations (iCF) final batch were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 2 (T2).
|
200 mg BI 730357 TF1 (R2)
n=14 Participants
2 tablets of 100 mg BI 730357 tablet formulation 1 were administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 2 (R2).
|
100 mg BI 730357 iCF, Unmilled API (T3u)
n=14 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3u (T3u).
|
100 mg BI 730357 iCF, Coarse-milled API (T3c)
n=15 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3c (T3c).
|
100 mg BI 730357 iCF, Regularly Milled API (R3)
n=14 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water, after an overnight fast of at least 10 h, as reference treatment 3 (R3).
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
5870.79 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.08
|
5197.06 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.08
|
19970.22 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
17292.36 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
5318.07 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.10
|
9028.63 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.10
|
11568.30 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.10
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint that was not excluded due to a protocol deviation or due to PK non-evaluability. It was sufficient for each subject to contribute only 1 PK parameter value for 1 period.
Maximum measured concentration of BI 730357 in plasma (Cmax).
Outcome measures
| Measure |
50 mg BI 730357 iCF (T1)
n=14 Participants
1 tablet of 50 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 1 (T1).
|
50 mg BI 730357 TF1 (R1)
n=14 Participants
1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 1 (R1).
|
200 mg BI 730357 iCF (T2)
n=14 Participants
2 tablets of 100 mg BI 730357 intended commercial formulations (iCF) final batch were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 2 (T2).
|
200 mg BI 730357 TF1 (R2)
n=14 Participants
2 tablets of 100 mg BI 730357 tablet formulation 1 were administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 2 (R2).
|
100 mg BI 730357 iCF, Unmilled API (T3u)
n=14 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3u (T3u).
|
100 mg BI 730357 iCF, Coarse-milled API (T3c)
n=15 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3c (T3c).
|
100 mg BI 730357 iCF, Regularly Milled API (R3)
n=14 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water, after an overnight fast of at least 10 h, as reference treatment 3 (R3).
|
|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 730357 in Plasma (Cmax)
|
257.57 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.07
|
178.10 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.07
|
605.33 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.06
|
466.75 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.06
|
175.51 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
317.95 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
423.42 nanomol/Liter (nmol/L)
Standard Error NA
Geometric Standard Error (gSE) = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint that was not excluded due to a protocol deviation or due to PK non-evaluability. It was sufficient for each subject to contribute only 1 PK parameter value for 1 period.
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
50 mg BI 730357 iCF (T1)
n=14 Participants
1 tablet of 50 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 1 (T1).
|
50 mg BI 730357 TF1 (R1)
n=14 Participants
1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 1 (R1).
|
200 mg BI 730357 iCF (T2)
n=14 Participants
2 tablets of 100 mg BI 730357 intended commercial formulations (iCF) final batch were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 2 (T2).
|
200 mg BI 730357 TF1 (R2)
n=14 Participants
2 tablets of 100 mg BI 730357 tablet formulation 1 were administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 2 (R2).
|
100 mg BI 730357 iCF, Unmilled API (T3u)
n=14 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3u (T3u).
|
100 mg BI 730357 iCF, Coarse-milled API (T3c)
n=15 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3c (T3c).
|
100 mg BI 730357 iCF, Regularly Milled API (R3)
n=14 Participants
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water, after an overnight fast of at least 10 h, as reference treatment 3 (R3).
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
6222.62 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.08
|
5600.47 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.08
|
21074.02 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.11
|
18464.52 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.11
|
5843.68 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.10
|
9585.79 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.09
|
11967.75 nanomol*hours/Liter (nmol*h/L)
Standard Error NA
Geometric Standard Error = 1.10
|
Adverse Events
50 mg BI 730357 iCF (T1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg BI 730357 TF1 (R1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
200 mg BI 730357 iCF (T2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
200 mg BI 730357 TF1 (R2)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
100 mg BI 730357 iCF, Unmilled API (T3u)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
100 mg BI 730357 iCF, Coarse-milled API (T3c)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 mg BI 730357 iCF, Regularly Milled API (R3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg BI 730357 iCF (T1)
n=14 participants at risk
1 tablet of 50 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 1 (T1).
|
50 mg BI 730357 TF1 (R1)
n=14 participants at risk
1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 1 (R1).
|
200 mg BI 730357 iCF (T2)
n=14 participants at risk
2 tablets of 100 mg BI 730357 intended commercial formulations (iCF) final batch were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 2 (T2).
|
200 mg BI 730357 TF1 (R2)
n=14 participants at risk
2 tablets of 100 mg BI 730357 tablet formulation 1 were administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as reference treatment 2 (R2).
|
100 mg BI 730357 iCF, Unmilled API (T3u)
n=14 participants at risk
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3u (T3u).
|
100 mg BI 730357 iCF, Coarse-milled API (T3c)
n=15 participants at risk
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) side batch with coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 mL water after an overnight fast of at least 10 h, as test treatment 3c (T3c).
|
100 mg BI 730357 iCF, Regularly Milled API (R3)
n=14 participants at risk
1 tablet of 100 mg BI 730357 intended commercial formulation (iCF) final batch was administered as a single oral dose with 240 mL water, after an overnight fast of at least 10 h, as reference treatment 3 (R3).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
6.7%
1/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
21.4%
3/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
42.9%
6/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
57.1%
8/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
13.3%
2/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
0.00%
0/15 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • [Serious and other adverse events]:Up to 7 days after drug administration. All-cause mortality was collected up to 16 days.
Adverse events are reported on the treated set (TS). The TS included all subjects who were randomized and treated with at least 1 dose of trial drug.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place