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

A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIIX 1 XX inhalation solution

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIIX 1 XX, rising doses	Drug: BIIX 1 XX inhalation solution; single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 1999
• Primary Completion (Actual): April 1, 1999

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1150.7