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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BIIX 1 XX inhalation solution

• Registration Number: NCT02198287
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 1999-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Last Update Submitted: 2014-07-22
• Study First Posted: 2014-07-23
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Excessive physical activities within two weeks prior to administration or during the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BIIX 1 XX, rising doses	BIIX 1 XX inhalation solution	-

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

Name	Time	Method
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
Maximum concentration of the drug in plasma (Cmax)	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