Trial Outcomes & Findings for This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated. (NCT NCT03588390)

NCT ID: NCT03588390

Last Updated: 2024-02-22

Results Overview

Percentage of participants with drug-related adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

63 participants

Primary outcome timeframe

From drug administration until end of trial, up to 15 days.

Results posted on

2024-02-22

Participant Flow

This single-rising dose trial was designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups.

All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensure that all participants met all strictly implemented inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo Matching BI 1323495 Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 1323495 Dose Group 1 Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 2 Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 3 Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 4 Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 5 Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 6 Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 7 Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 8 Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Overall Study STARTED	15	6	6	6	6	6	6	6	6
Overall Study COMPLETED	15	6	6	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Matching BI 1323495 n=15 Participants Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 1323495 Dose Group 1 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 2 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 3 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 4 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 5 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 6 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 7 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 8 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	Total n=63 Participants Total of all reporting groups
Age, Continuous	28.9 Years STANDARD_DEVIATION 6.0 • n=5 Participants	28.0 Years STANDARD_DEVIATION 7.6 • n=7 Participants	31.5 Years STANDARD_DEVIATION 6.4 • n=5 Participants	29.8 Years STANDARD_DEVIATION 8.9 • n=4 Participants	34.3 Years STANDARD_DEVIATION 5.4 • n=21 Participants	33.7 Years STANDARD_DEVIATION 8.6 • n=10 Participants	34.3 Years STANDARD_DEVIATION 6.5 • n=115 Participants	30.8 Years STANDARD_DEVIATION 4.1 • n=6 Participants	29.5 Years STANDARD_DEVIATION 5.2 • n=6 Participants	30.9 Years STANDARD_DEVIATION 6.6 • n=64 Participants
Sex: Female, Male Female	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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	63 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	63 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	63 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants

PRIMARY outcome

Timeframe: From drug administration until end of trial, up to 15 days.

Population: Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.

Percentage of participants with drug-related adverse events.

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1323495 n=15 Participants Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 1323495 Dose Group 1 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 2 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 3 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 4 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 5 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 6 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 7 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 8 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Percentage of Participants With Drug-related Adverse Events	6.7 Percentage of participants	50.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	50.0 Percentage of participants	16.7 Percentage of participants

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects from the TS receiving BI 1323495 who provided at least 1 secondary PK parameter 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 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) after single oral administration of BI 1323495.

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1323495 n=6 Participants Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 1323495 Dose Group 1 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 2 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 3 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 4 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 5 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 6 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 7 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 8 Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	143 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 102.0	883 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 118.0	824 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 77.7	2360 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 73.5	3710 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 69.4	3120 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 140.0	1780 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 102.0	3820 nanomole (nmol)*hours (h) /Liter (L) Geometric Coefficient of Variation 71.9	—

SECONDARY outcome

Population: PKS

Maximum measured concentration of BI 1323495 in plasma (Cmax) after single oral administration of BI 1323495.

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1323495 n=6 Participants Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablets with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 1323495 Dose Group 1 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 2 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 3 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 4 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 5 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 6 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 7 n=6 Participants Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 8 Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)	10.5 nmol/L Geometric Coefficient of Variation 66.3	59.4 nmol/L Geometric Coefficient of Variation 147.0	145.0 nmol/L Geometric Coefficient of Variation 74.8	229.0 nmol/L Geometric Coefficient of Variation 127.0	179.0 nmol/L Geometric Coefficient of Variation 152.0	136.0 nmol/L Geometric Coefficient of Variation 74.2	195.0 nmol/L Geometric Coefficient of Variation 90.8	195.0 nmol/L Geometric Coefficient of Variation 90.8	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Matching BI 1323495 n=15 participants at risk Participants were orally administered single dose of placebo matching to BI 1323495 film-coated tablet with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 1323495 Dose Group 1 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 1 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 2 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 2 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 3 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 3 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 4 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 4 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 5 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 5 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 6 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 6 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 7 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 7 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Dose Group 8 n=6 participants at risk Participants were orally administered single dose of BI 1323495 dose group 8 film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.	BI 1323495 Total n=48 participants at risk Participants were orally administered single dose of BI 1323495 dose groups 1, 2, 3, 4, 5, 6, 7 and 8 film-coated tablets with 240 mL of water after an overnight fast of at least 10 h.
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	4.2% 2/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
General disorders Fatigue	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	4.2% 2/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
General disorders Malaise	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
General disorders Unevaluable event	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
Infections and infestations Nasopharyngitis	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
Infections and infestations Rhinitis	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
Investigations Alanine aminotransferase increased	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
Investigations Glutamate dehydrogenase increased	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	2.1% 1/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.
Nervous system disorders Headache	13.3% 2/15 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	50.0% 3/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	0.00% 0/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	16.7% 1/6 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.	12.5% 6/48 • From drug administration until end of trial, up to 15 days. Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.

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