Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects

Single-dose Pharmacokinetics of 2.5 mg BIBB 515 BS and Effect of Food After Oral Administration of Capsules to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)

To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIBB 515 BS; Other: Standard breakfast (40 g fat)

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male caucasian subjects as determined by results of screening
• Written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

• Any finding 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 disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
• History of orthostatic hypotension, fainting spells or blackouts
• 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 results of the trial (≤ 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
• Excessive physical activities (≤ 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBB 515 BS after a standard breakfast	Drug: BIBB 515 BS; Other: Standard breakfast (40 g fat)
Active Comparator: BIBB 515 BS	Drug: BIBB 515 BS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	Up to 48 hours after last drug administration
Maximum concentration of the analyte in plasma (Cmax)	Up to 48 hours after drug administration
Time to reach maximum concentration of the analyte in plasma (tmax)	Up to 48 hours after drug administration
Apparent terminal elimination half-life of the analyte in plasma (t1/2)	Up to 48 hours after drug administration
Area under the concentration-time curve of the analyte in plasma at different time points (AUC)	Up to 48 hours after drug administration
Total mean residence time of the analyte in the body (MRTtot)	Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f)	Up to 48 hours after drug administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/f)	Up to 48 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)	Up to 48 hours after drug administration
Global clinical assessment by the investigator	Day 3 after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 1998
• Primary Completion (Actual): July 1, 1998

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Estimate): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 525.4