Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers

NCT02198287 | Completed Phase 1

• 1 other identifier: 1150.7
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with adverse events

  up to 22 days

• Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)

  up to 8 days after drug administration

• Number of patients with clinically relevant changes in electrocardiogram (ECG)

  up to 8 days after drug administration

• Number of patients with clinically relevant changes in impedance cardiography

  pre-dose, 10 and 30 minutes after administration

• Number of patients with clinically relevant changes in cutaneous microcirculation

  pre-dose, 10 and 30 minutes after administration

• Number of patients with clinically relevant changes in safety laboratory parameters

  up to 8 days after drug administration

Secondary Outcomes (4)

• Maximum concentration of the drug in plasma (Cmax)

  up to 168 hours after drug administration

• Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)

  up to 168 hours after drug administration

• Terminal half-life of the analyte in plasma (t1/2)

  up to 168 hours after drug administration

• Clearance, divided by f (CL/f)

  up to 168 hours after drug administration

Study Arms (2)

BIIX 1 XX, rising doses

EXPERIMENTAL

Drug: BIIX 1 XX inhalation solution

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIX 1 XX inhalation solution DRUG

single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg

BIIX 1 XX, rising doses

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males, based on a complete medical examination
• Age range from 21 to 50 years
• Participant must be within +/- 20 % of their normal weight (Broca-Index)
• Participant must provide written informed consent

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric 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 a drug with a long half-life (≥ 24 hours) within at least one month or less than then half-lives of the respective drug before enrolment in the study
• Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to start of the study
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse
• Drug abuse
• Blood donation (\> 100 ml) within four weeks prior to administration
• Other disease or abnormality of clinical relevance

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 22, 2014
• First Posted: July 23, 2014
• Study Start: January 1, 1999
• Primary Completion: April 1, 1999
• Last Updated: July 23, 2014

Record last verified: 2014-07