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

NCT02266498 | Completed Phase 1

• 1 other identifier: 525.4
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• 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

• Number of patients with adverse events

  Up to 48 hours after last drug administration

• Global clinical assessment by the investigator

  Day 3 after last drug administration

Study Arms (2)

BIBB 515 BS after a standard breakfast

EXPERIMENTAL

Drug: BIBB 515 BS; Other: Standard breakfast (40 g fat)

BIBB 515 BS

ACTIVE COMPARATOR

Drug: BIBB 515 BS

Interventions

BIBB 515 BS DRUG

BIBB 515 BS; BIBB 515 BS after a standard breakfast

Standard breakfast (40 g fat) OTHER

BIBB 515 BS after a standard breakfast

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 %

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

CD36 Antigens

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 17, 2014
• Study Start: June 1, 1998
• Primary Completion: July 1, 1998
• Last Updated: October 17, 2014

Record last verified: 2014-10