Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects

NCT02182388 | Completed Phase 1

• 1 other identifier: 1241.1
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with abnormal findings in physical examination

  Baseline, within 14 days after last trial procedure

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

  Baseline, up to 14 days after last trial procedure

• Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)

  Baseline, up to 14 days after last trial procedure

• Number of patients with abnormal changes in clinical laboratory tests

  Baseline, up to 14 days after last trial procedure

• Number of patients with adverse events

  up to 44 days

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

  within 14 days after last trial procedure

Secondary Outcomes (12)

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 72 hours after drug administration

Study Arms (3)

BI 207127 NA

EXPERIMENTAL

single rising dose part

Drug: BI 207127 NA powder for solution

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BI 207127 NA, fasted or fed

EXPERIMENTAL

Drug: BI 207127 NA powder for solution; Drug: BI 207127 NA tablet

Interventions

Placebo DRUG

Placebo

BI 207127 NA powder for solution DRUG

BI 207127 NA; BI 207127 NA, fasted or fed

BI 207127 NA tablet DRUG

BI 207127 NA, fasted or fed

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Any finding of the medical examination (including BP, PR 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
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nerve 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 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 or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• 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
• Alcohol abuse (more than 60 g/day)
• Inability to refrain from alcohol on trial days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

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: January 1, 2007
• Primary Completion: May 1, 2007
• Last Updated: July 18, 2014

Record last verified: 2014-07