Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects

NCT02182297 | Completed Phase 1

• 1 other identifier: 1220.13
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with abnormal findings in physical examination

  Baseline and within 7 days after last trial procedure

• Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)

  Baseline, pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose and day 12

• Number of patients with abnormal findings in 12-lead electrocardiography (ECG)

  Baseline, pre-dose and 1, 2, 4, 6, 8, 24, 48, 72 and 96 hours post-dose and day 12

• Number of patients with abnormal changes in laboratory tests (haematology, clinical chemistry, and urinalysis)

  Baseline, pre-dose and 24, 48, 72 and 96 hours post-dose and day 12

• Number of patients with adverse events

  up to day 12

• Assessment of tolerability by the investigator on a 4-point scale

  day 12 (within 7 days after last trial procedure)

Secondary Outcomes (12)

• Cmax (maximum concentration of the analyte in plasma)

  pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

• tmax (time from dosing to maximum concentration of the analyte in plasma)

  pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

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

  pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

• λz (terminal elimination rate constant in plasma)

  pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

Study Arms (2)

BI 201335 NA in single rising doses

EXPERIMENTAL

Drug: BI 201335 NA in single rising doses

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 201335 NA in single rising doses DRUG

BI 201335 NA in single rising doses

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be healthy male volunteers who meet the criteria below:
• Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
• Persons who are 20 or older and 35 or younger
• Persons with body mass index (BMI) of 18.5 kg/m2 or more and 25.0 kg/m2 less
• Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with the GCP (Good Clinical Practice)

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Prior history of jaundice
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• 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 prior to administration or during the trial
• Use of any drugs within 10 days prior to administration or during the trial
• Participation in another trial with an investigational product within four months prior to administration or during the trial
• Smoker (\>10 cigarettes, \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days (during hospitalisation and end of trial)
• Alcohol abuse (more than 60 g/day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: July 2, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: July 18, 2014

Record last verified: 2014-07