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Completed

NCT Number: NCT02254538

A Safety, Tolerability and Preliminary Pharmacokinetics of BILR 355 BS Single-rising Dose Study in Healthy Male Volunteers

Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS

Completed

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Key information

Conditions

Healthy

Age range

21 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

All participants in the study should be healthy males, ranging from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters).

In accordance with Good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

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
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
  • Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
  • Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
  • Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
  • Any laboratory value outside the clinically accepted reference range
  • Excessive physical activities within the last week before the trial or during the trial

Following exclusion criteria are of special interest for this study:

  • Erythema, exanthema and comparable skin alterations

Treatment and study plan

BILR 355 BS

Drug

PEG 400

Drug

Primary outcomes

  1. Number of participants with clinically significant changes in vital functions

    Time frame: Up to 10 days after drug administration

  2. Number of participants with abnormal findings in ECG (electrocardiogram)

    Time frame: Up to 10 days after drug administration

  3. Number of participants with abnormal findings in skin inspections

    Time frame: Up to 10 days after drug administration

  4. Number of participants with abnormal neurological finding

    Time frame: Up to 10 days after drug administration

  5. Number of participants with abnormal changes in laboratory parameters

    Time frame: Up to 10 days after drug administration

  6. Number of participants with positive faecal occult blood testing

    Time frame: Up to 10 days after drug administration

  7. Number of participants with adverse events

    Time frame: Up to 10 days after drug administration

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to 144 hours after drug administration

  2. Time to attain maximum plasma concentration (tmax)

    Time frame: Up to 144 hours after drug administration

  3. Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)

    Time frame: Up to 144 hours after drug administration

  4. Terminal half life (t½)

    Time frame: Up to 144 hours after drug administration

  5. Apparent clearance of the analyte in plasma following extravascular administration (CL/F)

    Time frame: Up to 144 hours after drug administration

  6. Total mean residence time (MRTtot)

    Time frame: Up to 144 hours after drug administration

  7. Apparent volume of distribution during the terminal elimination phase (Vz/F)

    Time frame: Up to 144 hours after drug administration

  8. Renal clearance of the analyte (CLR)

    Time frame: Up to 72 hours after drug administration

  9. Amount of drug excreted in the urine (Ae)

    Time frame: Up to 72 hours after drug administration

  10. Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)

    Time frame: Up to 144 hours after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Preliminary Pharmacokinetics Study in Healthy Male Volunteers After Oral Administration of BILR 355 BS Solved in PEG 400 (Dosage: 1 - 200 mg)

Important dates

Study start
2002
Primary completion
2003
First posted
Oct 2, 2014
Registry last updated
Oct 2, 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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