A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers

NCT02198313 | Terminated Phase 1

• 1 other identifier: 1150.3
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  up to day 28

• Number of subjects with abnormal changes in laboratory parameters

  up to day 21

• Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)

  up to day 21

• Number of subjects with clinically significant changes in ECG (Electrocardiogram)

  up to 21 days

Secondary Outcomes (6)

• AUC (Total Area under the plasma drug concentration time curve)

  up to 336 hours after last drug administration

• Cmax (maximum observed concentration of the analyte in plasma)

  up to 336 hours after last drug administration

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

  up to 336 hours after last drug administration

• t½ (Terminal half-life of the analyte in plasma)

  up to 336 hours after last drug administration

• MRT (mean time of residence of drug molecules in the body )

  up to 336 hours after last drug administration

Study Arms (4)

BIIX 1 XX - D1

EXPERIMENTAL

Drug: BIIX 1 XX - D1

BIIX 1 XX - D2

EXPERIMENTAL

Drug: BIIX 1 XX - D2

BIIX 1 XX - D3

EXPERIMENTAL

Drug: BIIX 1 XX - D3

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIX 1 XX - D1 DRUG

BIIX 1 XX - D1

BIIX 1 XX - D2 DRUG

BIIX 1 XX - D2

BIIX 1 XX - D3 DRUG

BIIX 1 XX - D3

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

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
• Any finding of the medical examination (including blood pressure, pulse rate or ECG) or laboratory tests deviating form 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 ten 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 the last two months prior to the start of the study
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• History of alcohol abuse and/or alcohol abuse
• Drug abuse

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: April 1, 1999
• Primary Completion: April 1, 1999
• Last Updated: August 31, 2018

Record last verified: 2018-08