Trial Outcomes & Findings for A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood (NCT NCT05945888)
NCT ID: NCT05945888
Last Updated: 2026-06-08
Results Overview
Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
From drug administration on Day 1 plus REP of 48 hours, up to 2 days.
Results posted on
2026-06-08
Participant Flow
This trial consisted of two parts, a single rising dose (SRD) part and food effect (FE) part in healthy men. The SRD part was a randomized, single-blind, and placebo-controlled trial, while the FE part was randomized, open-label, single dose, and two-way cross-over. The subjects in the SRD part were mutually exclusive with those in the FE part.
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Single Rising Dose (SRD): Placebo Matching BI 3000202
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 6 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R).
In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T).
There was a minimum 3-day washout period between the two treatments.
|
FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T).
In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R).
There was a minimum 3-day washout period between the two treatments.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
Baseline characteristics by cohort
| Measure |
SRD: Dose 1 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 6 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=14 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Food Effect (FE): Low Dose III BI 3000202 Fasted (R) / Fed (T)
n=6 Participants
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R).
In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T).
There was a minimum 3-day washout period between the two treatments.
|
FE: Low Dose III BI 3000202 Fed (T) / Fasted (R)
n=6 Participants
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T).
In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R).
There was a minimum 3-day washout period between the two treatments.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 Years
STANDARD_DEVIATION 3.9 • n=27 Participants
|
35.2 Years
STANDARD_DEVIATION 7.4 • n=267 Participants
|
30.2 Years
STANDARD_DEVIATION 8.8 • n=265 Participants
|
25.2 Years
STANDARD_DEVIATION 4.5 • n=568 Participants
|
36.2 Years
STANDARD_DEVIATION 4.5 • n=22 Participants
|
36.5 Years
STANDARD_DEVIATION 8.5 • n=23 Participants
|
30.2 Years
STANDARD_DEVIATION 7.4 • n=22 Participants
|
30.1 Years
STANDARD_DEVIATION 6.7 • n=9 Participants
|
34.7 Years
STANDARD_DEVIATION 5.1 • n=178 Participants
|
29.7 Years
STANDARD_DEVIATION 7.0 • n=116 Participants
|
32.1 Years
STANDARD_DEVIATION 7.1 • n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
6 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=22 Participants
|
14 Participants
n=9 Participants
|
6 Participants
n=178 Participants
|
6 Participants
n=116 Participants
|
68 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
6 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=22 Participants
|
14 Participants
n=9 Participants
|
6 Participants
n=178 Participants
|
6 Participants
n=116 Participants
|
68 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=22 Participants
|
14 Participants
n=9 Participants
|
6 Participants
n=178 Participants
|
6 Participants
n=116 Participants
|
66 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From drug administration on Day 1 plus REP of 48 hours, up to 2 days.Population: Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Outcome measures
| Measure |
SRD: Dose 6 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=14 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
|---|---|---|---|---|---|---|---|---|
|
SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administrationPopulation: Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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.
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'.
Outcome measures
| Measure |
SRD: Dose 6 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=10 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=12 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
|---|---|---|---|---|---|---|---|---|
|
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
|
—
|
—
|
901.43 Nanomoles times hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.19
|
768.45 Nanomoles times hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.19
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administrationPopulation: Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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.
Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'.
Outcome measures
| Measure |
SRD: Dose 6 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=10 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=12 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
|---|---|---|---|---|---|---|---|---|
|
FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
|
—
|
—
|
229.43 Nanomoles per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.25
|
219.06 Nanomoles per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.23
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administrationPopulation: Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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.
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24) was analyzed descriptively.
Outcome measures
| Measure |
SRD: Dose 6 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=5 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=5 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
|---|---|---|---|---|---|---|---|---|
|
SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
|
12500 Nanomoles times hour per Liter
Geometric Coefficient of Variation 49.6
|
—
|
115 Nanomoles times hour per Liter
Geometric Coefficient of Variation 28.8
|
386 Nanomoles times hour per Liter
Geometric Coefficient of Variation 25.8
|
1610 Nanomoles times hour per Liter
Geometric Coefficient of Variation 35.2
|
2570 Nanomoles times hour per Liter
Geometric Coefficient of Variation 56.8
|
4330 Nanomoles times hour per Liter
Geometric Coefficient of Variation 85.9
|
8440 Nanomoles times hour per Liter
Geometric Coefficient of Variation 31.0
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administrationPopulation: Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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.
Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively.
Outcome measures
| Measure |
SRD: Dose 6 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=6 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
n=6 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
|---|---|---|---|---|---|---|---|---|
|
SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
|
3670 Nanomoles times hour per Liter
Geometric Coefficient of Variation 63.1
|
—
|
48.8 Nanomoles times hour per Liter
Geometric Coefficient of Variation 63.1
|
65.0 Nanomoles times hour per Liter
Geometric Coefficient of Variation 87.4
|
535 Nanomoles times hour per Liter
Geometric Coefficient of Variation 42.5
|
614 Nanomoles times hour per Liter
Geometric Coefficient of Variation 52.9
|
1270 Nanomoles times hour per Liter
Geometric Coefficient of Variation 84.6
|
2430 Nanomoles times hour per Liter
Geometric Coefficient of Variation 43.7
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administrationPopulation: Pharmacokintetic (PK) parameter analysis set (PKS): This set included all participants 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.
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to infinity (AUC0-∞). The AUC0-∞ endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'.
Outcome measures
| Measure |
SRD: Dose 6 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=10 Participants
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=12 Participants
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
|---|---|---|---|---|---|---|---|---|
|
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)
|
—
|
—
|
1020.66 Nanomoles times hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.20
|
842.69 Nanomoles times hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.20
|
—
|
—
|
—
|
—
|
Adverse Events
SRD: Dose 6 - BI 3000202
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRD: Dose 7 - BI 3000202
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRD: Dose 2 - BI 3000202
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRD: Dose 3 - BI 3000202
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRD: Dose 4 - BI 3000202
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRD: Dose 5 - BI 3000202
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Rising Dose (SRD): Placebo Matching BI 3000202
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SRD: Dose 1 - BI 3000202
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FE Part: Low Dose III BI 3000202 Fed (= Test T)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SRD: Dose 6 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 7 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 2 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 3 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 4 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
SRD: Dose 5 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Single Rising Dose (SRD): Placebo Matching BI 3000202
n=14 participants at risk
SRD part: A single dose of placebo identical to active BI 3000202 was orally administered with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
SRD: Dose 1 - BI 3000202
n=6 participants at risk
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
|
Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R)
n=12 participants at risk
FE part: Participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (R).
|
FE Part: Low Dose III BI 3000202 Fed (= Test T)
n=12 participants at risk
FE part: Participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (T).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/14 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
8.3%
1/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
7.1%
1/14 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
7.1%
1/14 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
|
General disorders
Medical device site rash
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
7.1%
1/14 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
16.7%
1/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
14.3%
2/14 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
0.00%
0/6 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
16.7%
2/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
8.3%
1/12 • Adverse events: SRD & FE Part: from drug administration on Day 1, up to 2 days. All-Cause Mortality, from drug administration on Day 1 - until next drug administration or (FE only) - or end of trial, up to 14 days (SRD &FE).
Treated set (TS): The TS includes all participants who were treated with at least one dose of the trial drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place