Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 655064; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02331277

1293.9

Details and patient eligibility

About

The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Echocardiogram, and clinical laboratory tests

2. Chinese ethnicity according to the following criteria:

   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

3. Age within the range of 20 to 45 years inclusive

4. Body Mass Index within the range of 18.5 and 25 kg/m2 inclusive

5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

6. Male subjects who

   • are documented to be sterile or consistently and correctly use a condom while their female partners (if of childbearing potential) agree to use any of the following adequate contraception methods: implants, injectables, combined oral contraceptives, intrauterine device (IUD) from the date of screening until at least 6 months after the last dose of BI 655064 taken in the current trial.
   • do not donate any sperm sample for procreation purposes, from the date of screening until at least 6 months after last dose of BI 655064 taken in the current trial.

It is the responsibility of the male subject to ensure that his partner does not become pregnant during all the study duration.

Exclusion criteria

1. Any finding in the medical examination (including Blood pressure, Pulse rate or Echocardiogram) deviating from normal and judged clinically relevant by the investigator
2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
3. Any evidence of a concomitant disease judged clinically relevant by the investigator
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
5. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
6. History of relevant orthostatic hypotension, fainting spells, or blackouts
7. History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
8. Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
9. Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
10. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
12. Inability to refrain from smoking on trial days
13. Alcohol abuse (consumption of more than 20 g/day)
14. Drug abuse or positive drug screen
15. Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
16. Intention to commence new exercise regimen or excessive physical activities within one week prior to administration of trial medication or during the trial
17. Inability to comply with protocol requirements (including dietary regimen of trial site) as assessed by the investigator
18. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval > 450 ms) at screening examination
19. Positive results of infectious serology (Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody or Human Immunodeficiency Virus) at screening examination
20. History of tuberculosis infection and/or positive Quantiferon Tuberculosis-Gold test at screening examination
21. Abnormal results of coagulation values indicating an increased risk for bleeding or thromboembolism or complicating the safety evaluation during the study as determined by the investigator at screening examination
22. Subjects who in the investigator's judgement are perceived as having an excessive risk of thromboembolism for example because of a personal history and/or a first degree relative with a personal history with onset under the age of 55 of significant thromboembolism, including but not limited to deep vein thrombosis, pulmonary embolism, cortical sinus thrombosis, coronary and cerebrovascular events, and peripheral arterial insufficiency.
23. Deficiency of antithrombin III or protein S or protein C at screening examination
24. Prolongation of bleeding time out of reference range at screening examination
25. Subject is assessed by the investigator as unsuitable for inclusion e.g. considered not able to understand and comply with study requirements or has a condition that would not allow safe participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

BI 655064

Experimental group

Description:

Subjects received BI 655064 240 milligram (mg) via subcutaneous injection every week, until 4 weeks.

Treatment:

Drug: BI 655064

Placebo

Placebo Comparator group

Description:

Subjects received placebo matching to BI 655064 via subcutaneous injection every week, until 4 weeks.

Treatment:

Drug: Placebo