Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers

NCT02199873 | Completed Phase 1

• 1 other identifier: 1150.1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  up to 3 months

• Number of subjects with abnormal changes in laboratory parameters

  up to 8 days after last drug administration

• Change in impedance cardiography

  up to 30 minutes after drug administration

• Change in cutaneous microcirculation

  up to 30 minutes after drug administration

Secondary Outcomes (9)

• Change in airway resistance (Raw) after methacholine challenge

  up to 30 minutes after drug administration

• Change in specific conductance (sGaw) after methacholine challenge

  up to 30 minutes after drug administration

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

  up to 168 hours after drug administration

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 168 hours after drug administration

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

  up to 168 hours after drug administration

Study Arms (2)

BIIX 1 XX - single rising dose

EXPERIMENTAL

Drug: BIIX 1 XX - single rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIX 1 XX - single rising dose DRUG

BIIX 1 XX - single rising dose

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 male volunteers who have Broca-Indices within +-20%
• Participants in the age range between 21 to 50 years
• Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
• In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study

You may not qualify if:

• Haematopoietic, hepatic and renal function test will be carried out in the laboratory
• 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
• 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
• 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 one month before enrolment in the study
• Use of any drugs which might influence the results of the trial the week previous to the start of the study
• Participation in another study with an investigational drug within the last two months preceding this study
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 60g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: June 1, 1998
• Primary Completion: September 1, 1998
• Last Updated: October 29, 2014

Record last verified: 2014-10