CompletedNCT02256709Updated Oct 6, 2014

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

A Phase 1 interventional study of BIBP 5371 CL tablet and BIBP 5371 CL solution in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-06.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 70 participants (actual)

Study arms

Experimental
single rising dose BIBP 5371 CL
Drug: BIBP 5371 CL tablet
Experimental
BIBP 5371 CL tablet high dose
to be compared with same daily dose level from single rising dose arm
Drug: BIBP 5371 CL tablet high dose
Experimental
BIBP 5371 CL tablet low dose
to be compared with same daily dose level from single rising dose arm
Drug: BIBP 5371 CL tablet low dose
Placebo comparator
Placebo drinking solution
Drug: Placebo drinking solution
Experimental
BIBP 5371 CL drinking solution
Drug: BIBP 5371 CL solution
Experimental
BIBP 5371 CL tablet high dose with food
Other: High fat, high caloric breakfast · Drug: BIBP 5371 CL tablet high dose
Experimental
BIBP 5371 CL tablet low dose with food
Other: High fat, high caloric breakfast · Drug: BIBP 5371 CL tablet low dose
Placebo comparator
Placebo tablet
Drug: Placebo tablet

Interventions

DrugBIBP 5371 CL tablet
single rising daily doses
DrugBIBP 5371 CL solution
OtherHigh fat, high caloric breakfast
DrugPlacebo tablet
DrugBIBP 5371 CL tablet high dose
DrugPlacebo drinking solution
DrugBIBP 5371 CL tablet low dose

What researchers measure

Primary outcomes

Number of patients with changes in vital signs
blood pressure, pulse rate, respiratory rate, body temperature
Time frame: baseline, up to 8 days after drug administration
Number of patients with changes in electrocardiogram (ECG)
Time frame: baseline, up to 8 days after drug administration
Number of patients with changes in safety laboratory parameters
Time frame: baseline, up to 8 days after drug administration
Number of patients with adverse events
Time frame: baseline, up to 8 days after drug administration
Global tolerability assessment by the investigator on a verbal rating scale
Time frame: up to 8 days after drug administration

Secondary outcomes

Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 32 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 32 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 32 hours after drug administration
%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 32 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 32 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 32 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: up to 32 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 32 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 32 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 32 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 32 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 32 hours after drug administration

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02256709
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Oct 6, 2014
Start date: Apr 2004
Primary completion: Aug 2004
Last update: Oct 6, 2014

View the source record on ClinicalTrials.gov ↗

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