Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers

• ClinicalTrials.gov Identifier: NCT02203487
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Last Update Posted: July 30, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: BIIF 1149 BS - single rising dose; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Double-blind (Within Dose Groups), Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (Nine Days Treatment of 5 mg and 10 mg and Eighteen Days Treatment of 25 mg and 40 mg) of BIIF 1149 BS in Healthy Male Volunteers
• Study Start Date: November 1999
• Actual Primary Completion Date: June 2000

Arms and Interventions

Arm	Intervention/treatment
Experimental: BIIF 1149 BS - single rising dose	Drug: BIIF 1149 BS - single rising dose
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Number of subjects with adverse events [ Time Frame: up to 55 days ]
2. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 8 days after last blood sample ]
3. Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: up to 8 days after last blood sample ]

Secondary Outcome Measures :

1. Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG) [ Time Frame: up to 8 days after last blood sample ]
2. Cmax (Maximum concentration of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
3. Tmax (Time to maximum observed concentration of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
4. AUC (Area under the concentration-time curve of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
5. Ae (Urinary excretion of parent drug) [ Time Frame: up to 120 hours after last drug administration ]
6. Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: after 24 hours of drug administration on day 9 ]
7. MRT (Mean residence time of the analyte in the body) [ Time Frame: up to 360 hours after last drug administration ]
8. t½ (Terminal half-life of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
9. Percent peak-trough fluctuation [ Time Frame: up to 360 hours after last drug administration ]
10. RA (AUC) Accumulation factor based on AUC-data [ Time Frame: up to 360 hours after last drug administration ]
11. RA (Ae) Accumulation factor based on Ae-data [ Time Frame: up to 120 hours after last drug administration ]
12. RA (Cmax) Accumulation factor based on Cmax -data [ Time Frame: up to 360 hours after drug administration on day 9 ]
13. Cav (Average plasma concentration in a steady state interval) [ Time Frame: 24 hours after drug administration of day 9 ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Participants should be healthy males
• Age range from 21 to 50 years
• Within +- 20% of their normal weight (Broca-Index)
• In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study
• Each subject will have his medical history taken and will receive a complete medical examination (incl. demographics, medical history, check of inclusion/exclusion criteria, physical examination, vital signs, 12-lead Electrocardiogram (ECG)
• 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

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
• 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 ten half-lives of the respective drug before enrolment in the study
• Use of any other drugs which might influence the results of the trial during 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 (> 40g/day)
• Drug abuse
• Blood donation (>= 100 ml) within the last 4 weeks
• Excessive physical activities (e.g. competitive sports) within the last week before the study

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02203487
• Other Study ID Numbers: 1157.3
• First Posted: July 30, 2014
• Last Update Posted: July 30, 2014
• Last Verified: July 2014