Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Placebo
Drug: BIIF 1149 BS
Details and patient eligibility
About
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.
Enrollment
24 patients
Sex
Male
Ages
21 to 50 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
24 participants in 2 patient groups, including a placebo group
BIIF 1149 BS
Experimental group
Treatment:
Drug: BIIF 1149 BS
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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