Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers

NCT ID: NCT02256709

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

Brief Summary

Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

single rising dose BIBP 5371 CL

Group Type: EXPERIMENTAL

BIBP 5371 CL tablet

Intervention Type: DRUG

single rising daily doses

BIBP 5371 CL tablet high dose

to be compared with same daily dose level from single rising dose arm

Group Type: EXPERIMENTAL

BIBP 5371 CL tablet high dose

Intervention Type: DRUG

BIBP 5371 CL tablet low dose

to be compared with same daily dose level from single rising dose arm

Group Type: EXPERIMENTAL

BIBP 5371 CL tablet low dose

Intervention Type: DRUG

Placebo drinking solution

Group Type: PLACEBO_COMPARATOR

Placebo drinking solution

Intervention Type: DRUG

BIBP 5371 CL drinking solution

Group Type: EXPERIMENTAL

BIBP 5371 CL solution

Intervention Type: DRUG

BIBP 5371 CL tablet high dose with food

Group Type: EXPERIMENTAL

High fat, high caloric breakfast

Intervention Type: OTHER

BIBP 5371 CL tablet high dose

Intervention Type: DRUG

BIBP 5371 CL tablet low dose with food

Group Type: EXPERIMENTAL

High fat, high caloric breakfast

Intervention Type: OTHER

BIBP 5371 CL tablet low dose

Intervention Type: DRUG

Placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Interventions

BIBP 5371 CL tablet

single rising daily doses

Intervention Type: DRUG

BIBP 5371 CL solution

Intervention Type: DRUG

High fat, high caloric breakfast

Intervention Type: OTHER

Placebo tablet

Intervention Type: DRUG

BIBP 5371 CL tablet high dose

Intervention Type: DRUG

Placebo drinking solution

Intervention Type: DRUG

BIBP 5371 CL tablet low dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and female volunteers
• Age 21 - 50 years
• Body mass index (BMI) 18.5 - 29.9 kg/m2

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system or psychiatric disorders or neurological disorders
• History of relevant 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 drugs with a long half-life (> 24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
• Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial)
• Participation in another trial with an investigational drug (within 2 months prior to administration or during the trial)
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (> 60 grams/day)
• Drug abuse
• Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range of clinical relevance

In addition, for female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation

Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study

• Inability to maintain this adequate contraception during the whole study period
• Lactation period

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1214.1

Identifier Type: -

Identifier Source: org_study_id