Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of BI 11634 Oral Solution in Healthy Male Volunteers

NCT02214940 | Completed Phase 1

• 1 other identifier: 1234.2
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in a statistical sense defined)

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of subjects with adverse events

  up to 10 days after last drug administration

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

  up to 10 days after last drug administration

• Number of subjects with clinically significant findings in ECG

  up to 10 days after last drug administration

• Number of subjects with clinically significant findings laboratory tests

  up to 10 days after last drug administration

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

  up to 10 days after last drug administration

Secondary Outcomes (28)

• Cmax (maximum measured concentration of analyte in plasma)

  up to 144 hours after first drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 144 hours after first drug administration

• AUCτ,n (area under the concentration-time curve of analyte in plasma over a uniform dosing interval τ after administration of the n-th dose)

  up to 144 hours after first drug administration

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

  up to 144 hours after first drug administration

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

  up to 144 hours after first drug administration

Study Arms (2)

BI 11634

EXPERIMENTAL

multiple rising dose

Drug: BI 11634

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 11634 DRUG

BI 11634

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy Caucasian males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
• Age ≥18 and ≤50 years
• Haemoglobin within the normal ranges
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation

You may not qualify if:

• Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute and chronic blood coagulation defect, for the subject itself or any person of his family as far as known
• History of gastric ulcera and cholecystectomy
• Occult blood in feces
• Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Relevant chronic or 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 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
• Participation in another trial with an investigational drug within two 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 as judged by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

N-(1-(5-chloro-1H-benzimidazol-2-yl)-2-methoxyethyl)-3-methyl-4-(3-oxo-4-morpholinyl)benzamide

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: August 12, 2014
• First Posted: August 13, 2014
• Study Start: June 1, 2007
• Primary Completion: September 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08