Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers

NCT01922349 | Completed Phase 1 Results

• 1 other identifier: 1314.9
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• Cmax (Maximum Measured Concentration of the Analyte in Plasma)

  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)

  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

• Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)

  0.25h, 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

• AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)

  0.25h, 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

• t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)

  0.25h, 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

Study Arms (8)

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

EXPERIMENTAL

High dose

Drug: BI 113608

Placebo (Single dose)

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BI 113608 DRUG

Medium dose (Multiple dosing)

Dose 5, Multiple dose

Placebo DRUG

Placebo (Multiple dosing)

Placebo (Multiple dose)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1314.9.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 14, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 20, 2017
• Results First Posted: January 20, 2017

Record last verified: 2014-08

Locations

KR (1)