Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers

A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Citric Acid Challenge) Study After Oral Administration of BIIF 1149 BS (Single Doses as Tablets: 40, 65, 100 mg) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel Groups)

The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIIF 1149 BS

• Study Type: Interventional
• Enrollment (Actual): 24
• 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
• +/- 20 % of their normal weight (Broca-Index)
• Written informed consent

Exclusion Criteria:

• Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections (especially respiratory infections, cough)
• Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
• Volunteers who received any other drugs which might influence the results of the study during the week prior to the start of the study
• Volunteers who have participated in another study with an investigational drug within the last 2 months preceding this study
• Volunteers who smoke more than 10 cigarettes (or equivalent) per day
• Volunteers who are not able to refrain from smoking on study days
• Volunteers who drink more than 40 g of alcohol per day
• Volunteers who are dependent on drugs
• Volunteers who are participated in excessive physical activities (e.g. competitive sports) during the last week before the study
• Volunteers who have donated blood (≥ 100 ml) within the last four weeks

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: BIIF 1149 BS	Drug: BIIF 1149 BS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 8 days after last drug administration
Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate)	up to 8 days after last drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)	up to 8 days after last drug administration
Number of patients with clinically relevant changes in laboratory parameters	up to 8 days after last drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum drug plasma concentration (Cmax)		up to 360 hours after drug administration
Time to reach maximum drug concentration (tmax)		up to 360 hours after drug administration
Total area under the plasma drug concentration-time curve (AUC) for several time points		up to 360 hours after drug administration
Terminal half-life (t1/2)		up to 360 hours after drug administration
Mean residence time (MRT)		up to 360 hours after drug administration
Total clearance after oral administration (CLtot/f)		up to 360 hours after drug administration
Amount of drug excreted in urine (Ae)		up to 360 hours after drug administration
Measurement of pharmacodynamic activity	Citric acid challenge	Screening, at least 15 days after first administration
Volume of Distribution during terminal phase after oral administration (Vz/F)		up to 360 hours after drug administration
Renal clearance in the time interval form 0 to x h (Clren0-xh)		up to 360 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: November 1, 1999
• Primary Completion (Actual): February 1, 2000

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1157.4