Metabolism and Pharmacokinetics of [14C]-BIIL 284 BS in Healthy Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C] BILL 284 BS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02266550

543.16

Details and patient eligibility

About

The aims of this phase I study are to define the metabolism, excretion and pharmacokinetics of [14C]-BIIL 284 BS after administration of a single oral dose of 25 mg [14C]-BIIL 284 BS in 6 healthy volunteers. Tolerability was also assessed.

Enrollment

6 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers, range from 30 to 55 years of age inclusive
Body weight between 50 and 100 kg and within ± 20% of ideal body weight
No clinically significant abnormal physical findings at the screening examination which would interfere with the objective of the study
No clinically relevant abnormalities in the results of laboratory screening evaluation
Normal ECG
Normal Blood pressure (between 100 to 150 mmHg systolic and 50 to 90 mmHg diastolic) and heart rate (between 50 to 90 beats per minute)
Able to communicate well with the investigator and to comply with the requirements of the entire study
Provision of written informed consent to participate as shown by a signature on the volunteer consent form
Non-smokers

Exclusion criteria

Medical examination or laboratory test results that are judged by the clinical investigator to differ significantly from normal clinical values
Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Current disease of the central nervous system (such as epilepsy) or with psychiatric disorders)
Known history of orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
Intake of any drugs which might influence the results of the trial during the week previous to the start of the study
Administration of any investigational drug in the period 3 months before entry to the study (4 months if the previous drug was a new chemical entity)
A need for any medication within the two weeks before dosing
Existence of any surgical or medical condition which, in the judgement of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug (e.g. renal or hepatic impairments)
Presence of clinically relevant history of allergy/hypersensitivity (including drug allergy)
Blood loss or donation within the last 12 weeks (≥ 400 ml)
Serious adverse reaction/hypersensitivity to any drug
Objection by the subject's general practitioner to his/her patient's participation in the study
Positive results for drug screening as listed in the protocol, positive results for hepatitis B surface antigen, Anti hepatitis B core antibodies, Anti hepatitis C virus antibodies and human immunodeficiency test, Glucose 6 - Phosphate Dehydrogenase
Inability to communicate or co-operate with the investigator due to language problem, poor mental development or impaired cerebral function
Administration of radiolabelled substance or exposure to significant radiation (e.g. serial X-ray, or CT scans, barium meal, etc) within the past 12 months
History of recent drug abuse
Volunteers who drink more than 4 units of alcohol per day and/or have been consuming alcohol during the 24 hours before dosing
Participation in excessive physical activities (e.g. competitive sports) within the last week before the study