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OpenTrials
Completed

NCT Number: NCT02266498

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

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIBB 515 BS

Drug

Standard breakfast (40 g fat)

Other

Primary outcomes

  1. Maximum concentration of the analyte in plasma (Cmax)

    Time frame: Up to 48 hours after drug administration

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

    Time frame: Up to 48 hours after drug administration

  3. Apparent terminal elimination half-life of the analyte in plasma (t1/2)

    Time frame: Up to 48 hours after drug administration

  4. Area under the concentration-time curve of the analyte in plasma at different time points (AUC)

    Time frame: Up to 48 hours after drug administration

  5. Total mean residence time of the analyte in the body (MRTtot)

    Time frame: Up to 48 hours after drug administration

  6. Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f)

    Time frame: Up to 48 hours after drug administration

  7. Apparent volume of distribution of the analyte during the terminal phase (Vz/f)

    Time frame: Up to 48 hours after drug administration

  8. Terminal rate constant of the analyte in plasma (λz)

    Time frame: Up to 48 hours after drug administration

  9. Number of patients with adverse events

    Time frame: Up to 48 hours after last drug administration

  10. Global clinical assessment by the investigator

    Time frame: Day 3 after last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
1998
Primary completion
1998
First posted
Oct 17, 2014
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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