Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers

NCT02259894 | Completed Phase 1

• 1 other identifier: 1206.1
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events

  Up to 16 days after drug administration

• Number of participants with clinically significant changes in vital signs

  Up to 16 days after drug administration

• Number of participants with abnormal changes in clinical laboratory parameters

  Up to 16 days after drug administration

• Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)

  Up to 16 days after drug administration

• Number of participants with abnormal findings in physical examination

  Screening and up to 16 days after drug administration

Secondary Outcomes (14)

• Cmax (maximum concentration in plasma)

  Up to 360 hours after drug administration

• tmax (time from dosing to maximum concentration)

  Up to 360 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 360 hours after drug administration

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

  Up to 360 hours after drug administration

• λz (terminal rate constant in plasma)

  Up to 360 hours after drug administration

Study Arms (2)

BIRT 2584

EXPERIMENTAL

single rising doses

Drug: BIRT 2584 XX

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIRT 2584 XX DRUG

BIRT 2584

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 male subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age \>=18 and \<=50 years
• BMI \>=18.5 and \<=29.9 kg/m2

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Relevant 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) (\< 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial, (\< 10 days prior to study drug administration or expected during the trial)
• Participation in another trial with an investigational drug (\< 2 months prior to administration or expected during trial)
• Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation or loss \> 400 mL, \< 1 month prior to administration or expected during the trial
• Clinically relevant laboratory abnormalities

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: October 7, 2014
• First Posted: October 9, 2014
• Study Start: March 1, 2004
• Primary Completion: June 1, 2004
• Last Updated: October 9, 2014

Record last verified: 2014-10