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

NCT02254538 | Completed Phase 1

• 1 other identifier: 1188.1
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Number of participants with clinically significant changes in vital functions

  Up to 10 days after drug administration

• Number of participants with abnormal findings in ECG (electrocardiogram)

  Up to 10 days after drug administration

• Number of participants with abnormal findings in skin inspections

  Up to 10 days after drug administration

• Number of participants with abnormal neurological finding

  Up to 10 days after drug administration

• Number of participants with abnormal changes in laboratory parameters

  Up to 10 days after drug administration

• Number of participants with positive faecal occult blood testing

  Up to 10 days after drug administration

• Number of participants with adverse events

  Up to 10 days after drug administration

Secondary Outcomes (10)

• Maximum plasma concentration (Cmax)

  Up to 144 hours after drug administration

• Time to attain maximum plasma concentration (tmax)

  Up to 144 hours after drug administration

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

  Up to 144 hours after drug administration

• Terminal half life (t½)

  Up to 144 hours after drug administration

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

  Up to 144 hours after drug administration

Study Arms (2)

BILR 355 BS

EXPERIMENTAL

escalating doses

Drug: BILR 355 BS; Drug: PEG 400

Placebo

PLACEBO COMPARATOR

Drug: PEG 400

Interventions

BILR 355 BS DRUG

BILR 355 BS

PEG 400 DRUG

BILR 355 BS; Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

polyethylene glycol 400

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 2, 2014
• Study Start: May 1, 2002
• Primary Completion: February 1, 2003
• Last Updated: October 2, 2014

Record last verified: 2014-09