Skip to main content
OpenTrials
Completed

NCT Number: NCT02256709

Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers

Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

All sexes

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 and female volunteers
  • Age 21 - 50 years
  • Body mass index (BMI) 18.5 - 29.9 kg/m2

Exclusion criteria

  • Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system or psychiatric disorders or neurological disorders
  • History of relevant 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) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
  • Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial)
  • Participation in another trial with an investigational drug (within 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 trial days
  • Alcohol abuse (> 60 grams/day)
  • Drug abuse
  • Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
  • Excessive physical activities (within the last week before the study)
  • Any laboratory value outside the reference range of clinical relevance

In addition, for female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation

Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study

  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

Treatment and study plan

BIBP 5371 CL tablet

Drug

single rising daily doses

BIBP 5371 CL solution

Drug

High fat, high caloric breakfast

Other

Placebo Tablet

Drug

BIBP 5371 CL tablet high dose

Drug

Placebo drinking solution

Drug

BIBP 5371 CL tablet low dose

Drug

Primary outcomes

  1. Number of patients with changes in vital signs

    Time frame: baseline, up to 8 days after drug administration

    blood pressure, pulse rate, respiratory rate, body temperature

  2. Number of patients with changes in electrocardiogram (ECG)

    Time frame: baseline, up to 8 days after drug administration

  3. Number of patients with changes in safety laboratory parameters

    Time frame: baseline, up to 8 days after drug administration

  4. Number of patients with adverse events

    Time frame: baseline, up to 8 days after drug administration

  5. Global tolerability assessment by the investigator on a verbal rating scale

    Time frame: up to 8 days after drug administration

Secondary outcomes

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

    Time frame: up to 32 hours after drug administration

  2. tmax (time from dosing to maximum concentration)

    Time frame: up to 32 hours after drug administration

  3. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 32 hours after drug administration

  4. %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)

    Time frame: up to 32 hours after drug administration

  5. λz (terminal rate constant in plasma)

    Time frame: up to 32 hours after drug administration

  6. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: up to 32 hours after drug administration

  7. MRTpo (mean residence time of the analyte in the body after po administration)

    Time frame: up to 32 hours after drug administration

  8. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Time frame: up to 32 hours after drug administration

  9. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Time frame: up to 32 hours after drug administration

  10. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)

    Time frame: up to 32 hours after drug administration

  11. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)

    Time frame: up to 32 hours after drug administration

  12. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)

    Time frame: up to 32 hours after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect

Important dates

Study start
2004
Primary completion
2004
First posted
Oct 6, 2014
Registry last updated
Oct 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.