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

NCT02229838 | Completed Phase 1

• 1 other identifier: 1178.1
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (14)

• Maximum drug plasma concentration (Cmax)

  Up to 38 hours after drug administration

• Time to reach the maximum concentration of the analyte in plasma (tmax)

  Up to 38 hours after drug administration

• Total area under the plasma drug concentration-time curve (AUC)

  Up to 38 hours after drug administration

• Apparent terminal half-life of the analyte in plasma (t1/2)

  Up to 38 hours after drug administration

• Total plasma clearance divided by the systemic availability factor (CL/f)

  Up to 38 hours after drug administration

• Dose normalized AUC0-38h ( NAUC0-38h)

  Up to 38 h after drug administration

• Mean residence time, total (MRTtot)

  Up to 38 hours after drug administration

• Number of patients with adverse events

  Up to 72 hours after last drug administration

• Number of patients with clinical significant findings in vital signs

  Up to 38 hours after drug administration

• Number of patients with clinical significant findings in electrocardiogram (ECG)

  Up to 38 hours after drug administration

• Number of patients with clinical significant findings in physical examination

  Up to 38 hours after drug administration

• Investigator assessed tolerability on a 4 point scale

  Up to 38 hours after drug administration

• Monoepoxysqualene (MES) plasma concentration

  Up to 38 hours after drug administration

• Amount of drug excreted in urine

  Up to 38 h after drug administration

Study Arms (4)

BIBB 1464 MS single rising dose fed

EXPERIMENTAL

Drug: BIBB 1464 MS tablet; Other: Standard dinner

BIBB 1464 MS tablet fasted

EXPERIMENTAL

Drug: BIBB 1464 MS tablet

BIBB 1464 MS solution fasted

ACTIVE COMPARATOR

Drug: BIBB 1464 MS solution

BIBB 1464 MS placebo

PLACEBO COMPARATOR

Drug: BIBB 1464 MS placebo

Interventions

BIBB 1464 MS tablet DRUG

BIBB 1464 MS single rising dose fed; BIBB 1464 MS tablet fasted

BIBB 1464 MS solution DRUG

BIBB 1464 MS solution fasted

BIBB 1464 MS placebo DRUG

BIBB 1464 MS placebo

Standard dinner OTHER

BIBB 1464 MS single rising dose fed

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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 28, 2014
• First Posted: September 1, 2014
• Study Start: July 1, 1999
• Primary Completion: September 1, 1999
• Last Updated: September 1, 2014

Record last verified: 2014-08