Trial Outcomes & Findings for Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects (NCT NCT02148107)

Results Overview

Percentage of subjects with drug-related Adverse events (AEs)

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days

Results posted on

2016-02-29

Participant Flow

The trial was terminated early therefore only the first 2 dose levels planned (0.5 mg and 3.0 mg) were administered. In addition, due to recruitment problems fewer subjects than planned were randomised into the placebo and BI 691751 3mg groups.

Participant milestones

Participant milestones
Measure	BI 691751 0.5mg Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days	BI 691751 3mg Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.	Placebo Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
Overall Study STARTED	8	7	3
Overall Study COMPLETED	8	7	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 691751 0.5mg n=8 Participants Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days	BI 691751 3mg n=7 Participants Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.	Placebo n=3 Participants Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.	Total n=18 Participants Total of all reporting groups
Age, Continuous	33.5 Years STANDARD_DEVIATION 5.9 • n=5 Participants	29.7 Years STANDARD_DEVIATION 2.8 • n=7 Participants	33.3 Years STANDARD_DEVIATION 2.1 • n=5 Participants	32.0 Years STANDARD_DEVIATION 4.6 • n=4 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
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants

PRIMARY outcome

Timeframe: From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days

Population: Treated set

Percentage of subjects with drug-related Adverse events (AEs)

Outcome measures

Outcome measures
Measure	BI 691751 0.5mg n=8 Participants Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days	BI 691751 3mg n=7 Participants Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.	Placebo n=3 Participants Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
Percentage of Subjects With Drug-related Adverse Events	0 Percentage of participants	28.6 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration

Population: PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.

AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration

Population: PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.

Cmax (maximum measured concentration of the analyte inplasma). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration

Population: PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.

AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration

Population: PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.

Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

BI 691751 0.5mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BI 691751 3mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=3 participants at risk Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.	BI 691751 0.5mg n=8 participants at risk Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days	BI 691751 3mg n=7 participants at risk Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	28.6% 2/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Gastrointestinal disorders Flatulence	0.00% 0/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	28.6% 2/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
General disorders Chills	0.00% 0/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	14.3% 1/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
General disorders Malaise	0.00% 0/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	12.5% 1/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Infections and infestations Nasopharyngitis	0.00% 0/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	28.6% 2/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Infections and infestations Rhinitis	33.3% 1/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	0.00% 0/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	14.3% 1/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Nervous system disorders Headache	33.3% 1/3 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	12.5% 1/8 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	14.3% 1/7 • From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days

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 Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER