Safety, Tolerability and Pharmacokinetics of BI 113608 in... | NCT01922349

NCT01922349

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo (Multiple dose)	Placebo Comparator	Placebo	Drug: Placebo
Dose 1, Single dose	Experimental	Low dose	Drug: BI 113608
Dose 2, Single dose	Experimental	Medium dose	Drug: BI 113608
Dose 3, Single dose	Experimental	High dose	Drug: BI 113608
Dose 4, Multiple dose	Experimental	Low dose	Drug: BI 113608
Dose 5, Multiple dose	Experimental	Medium dose	Drug: BI 113608
Dose 6, Multiple dose

Name	Type	Description	Arm Group Labels	Other Names
BI 113608	Drug	Medium dose (Multiple dosing)	Dose 5, Multiple dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number (%) of Subjects With Drug-related Adverse Events	Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.	Up to 21 days (4 days for SRD period and 17 days for MRD period)

Secondary Outcomes

Measure	Description	Time Frame
Cmax (Maximum Measured Concentration of the Analyte in Plasma)	maximum measured concentration of the analyte in plasma after a single dose of BI 113608.	0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)

Eligibility Module

Eligibility Criteria

Inclusion criteria:

-Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, clinical laboratory tests

Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan Chinese; ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
Caucasian
Age older than 20 and younger than 45 years
Normal lung function testing
Normal peripheral oxygen saturation as determined by non-invasive pulse oxymetry
Body Mass Index more than 18.5 and Body Mass Index less than 25 kg/m2 for Japanese and Chinese
Body Mass Index more than 18.5 and Body Mass Index less than 29.9 kg/m2 for Caucasians
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

Exclusion criteria:

Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 20 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Arm/Group Information

ID	Title	Description
FG000	Placebo	Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
FG001	BI 113608 - 10 mg	2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
FG002	BI 113608 - 25 mg	1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
FG003	BI 113608 - 50 mg	2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
BG001	BI 113608 - 10 mg

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number (%) of Subjects With Drug-related Adverse Events

Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.

Treated set (TS)

Posted

Number

Percentage of participants

Up to 21 days (4 days for SRD period and 17 days for MRD period)

ID	Title	Description
OG000	Placebo	Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
OG001	BI 113608 - 10 mg	2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo- Chinese	Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects