Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Standard dinner; Drug: BIBB 1464 MS placebo; Drug: BIBB 1464 MS tablet; Drug: BIBB 1464 MS solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02229838

1178.1

Details and patient eligibility

About

Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).

Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)

Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

Enrollment: 73 patients

Sex: Male

Ages: 19 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age > 18 and < 55 years
• Broca > - 20% and < + 20%

Exclusion criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
• Surgery of the gastro-intestinal tract (except appendectomy)
• Disease of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
• Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (<= 2 month prior to administration or during the trial)
• Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
• Inability to refrain from smoking during the period of the study
• Known alcohol (>60 g/day) or drug abuse
• Blood donation (<=1 month prior to administration)
• Excessive physical activities (<5 days prior to administration)
• Any laboratory value outside the normal range of clinical relevance
• History of hemorrhagic diatheses
• History of gastro-intestinal ulcer, perforation or bleeding
• History of bronchial asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 4 patient groups, including a placebo group

BIBB 1464 MS single rising dose fed

Experimental group

Treatment:

Other: Standard dinner

Drug: BIBB 1464 MS tablet

BIBB 1464 MS tablet fasted

Experimental group

Treatment:

Drug: BIBB 1464 MS tablet

BIBB 1464 MS solution fasted

Active Comparator group

Treatment:

Drug: BIBB 1464 MS solution

BIBB 1464 MS placebo

Placebo Comparator group

Treatment:

Drug: BIBB 1464 MS placebo