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

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ClinicalTrials.gov Identifier: NCT02254538
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BILR 355 BS Drug: PEG 400 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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)
Study Start Date : May 2002
Actual Primary Completion Date : February 2003

Arm Intervention/treatment
Experimental: BILR 355 BS
escalating doses
Drug: BILR 355 BS
Drug: PEG 400
Placebo Comparator: Placebo Drug: PEG 400



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254538    
Other Study ID Numbers: 1188.1
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014