Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal

NCT02260037 | Completed Phase 1

• 1 other identifier: 262.261
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, tolerability and pharmacokinetics

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with clinically relevant findings in vital signs

  blood pressure, pulse rate

  up to 8 days after drug administration

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

  up to 8 days after drug administration

• Number of patients with adverse events

  up to 8 days after drug administration

• Number of patients with clinically relevant findings in laboratory parameters

  up to 8 days after drug administration

• Changes in rhinoscopy assessment

  up to 8 days after drug administration

Secondary Outcomes (11)

• Maximum measured concentration in plasma (Cmax)

  up to 48 hours after drug administration

• Time from dosing to the maximum concentration in plasma (tmax)

  up to 48 hours drug administration

• Area under the concentration-time curve in plasma (AUC)

  up to 48 hours after drug administration

• Terminal rate constant of in plasma (λz)

  up to 48 hours after drug administration

• Apparent terminal half-life in plasma (t1/2)

  up to 48 hours after drug administration

Study Arms (2)

Epinastine nasal

EXPERIMENTAL

single rising doses

Drug: Epinastine nasal

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Epinastine nasal DRUG

Epinastine nasal

Placebo DRUG

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, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca -Index)
• Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG. Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscientia Ingelheim, Germany). The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
• 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
• Surgery of the gastro-intestinal tract (except appendectomy)
• 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
• Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during the trial)
• Participation in another trial with an investigational drug (≤ 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 (\> 60 g/day)
• Drug abuse
• Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• 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: August 1, 2001
• Primary Completion: September 1, 2001
• Last Updated: October 9, 2014

Record last verified: 2014-10