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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBP 5371 CL tablet low dose; Drug: BIBP 5371 CL tablet; Other: High fat, high caloric breakfast; Drug: BIBP 5371 CL tablet high dose; Drug: Placebo drinking solution; Drug: BIBP 5371 CL solution; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02256709

1214.1

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 8 patient groups, including a placebo group

single rising dose BIBP 5371 CL

Experimental group

Treatment:

Drug: BIBP 5371 CL tablet

BIBP 5371 CL tablet high dose

Experimental group

Description:

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

Treatment:

Drug: BIBP 5371 CL tablet high dose

BIBP 5371 CL tablet low dose

Experimental group

Description:

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

Treatment:

Drug: BIBP 5371 CL tablet low dose

Placebo drinking solution

Placebo Comparator group

Treatment:

Drug: Placebo drinking solution

BIBP 5371 CL drinking solution

Experimental group

Treatment:

Drug: BIBP 5371 CL solution

BIBP 5371 CL tablet high dose with food

Experimental group

Treatment:

Drug: BIBP 5371 CL tablet high dose

Other: High fat, high caloric breakfast

BIBP 5371 CL tablet low dose with food

Experimental group

Treatment:

Drug: BIBP 5371 CL tablet low dose

Other: High fat, high caloric breakfast

Placebo tablet

Placebo Comparator group

Treatment:

Drug: Placebo tablet