HealthyPhase 1NCT02256709
Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
A Phase 1 study testing BIBP 5371 CL tablet, BIBP 5371 CL solution and High fat, high caloric breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect) Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBP 5371 CL tablet, BIBP 5371 CL solution and High fat, high caloric breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Aug 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers
- Age 21 - 50 years
- Body mass index (BMI) 18.5 - 29.9 kg/m2
Who cannot join
- 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
Show all 23Show fewer
- 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
About this study
Official title: Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
- Conditions
- Healthy
- Being tested
- BIBP 5371 CL tablet, BIBP 5371 CL solution, High fat, high caloric breakfast, Placebo tablet, BIBP 5371 CL tablet high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBP 5371 CL tabletDrug
single rising daily doses
BIBP 5371 CL solutionDrug
High fat, high caloric breakfastOther
Placebo tabletDrug
BIBP 5371 CL tablet high doseDrug
Placebo drinking solutionDrug
BIBP 5371 CL tablet low doseDrug
| Study group | Role | What they receive |
|---|---|---|
| single rising dose BIBP 5371 CL | Experimental | Not described Receives: Drug: BIBP 5371 CL tablet |
| BIBP 5371 CL tablet high dose | Experimental | to be compared with same daily dose level from single rising dose arm Receives: Drug: BIBP 5371 CL tablet high dose |
| BIBP 5371 CL tablet low dose | Experimental | to be compared with same daily dose level from single rising dose arm Receives: Drug: BIBP 5371 CL tablet low dose |
| Placebo drinking solution | Placebo comparator | Not described Receives: Drug: Placebo drinking solution |
| BIBP 5371 CL drinking solution | Experimental | Not described Receives: Drug: BIBP 5371 CL solution |
| BIBP 5371 CL tablet high dose with food | Experimental | Not described Receives: Other: High fat, high caloric breakfast; Drug: BIBP 5371 CL tablet high dose |
| BIBP 5371 CL tablet low dose with food | Experimental | Not described Receives: Other: High fat, high caloric breakfast; Drug: BIBP 5371 CL tablet low dose |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with changes in vital signs
blood pressure, pulse rate, respiratory rate, body temperature
Measured: baseline, up to 8 days after drug administration
Number of patients with changes in electrocardiogram (ECG)
Measured: baseline, up to 8 days after drug administration
Number of patients with changes in safety laboratory parameters
Measured: baseline, up to 8 days after drug administration
Number of patients with adverse events
Measured: baseline, up to 8 days after drug administration
Global tolerability assessment by the investigator on a verbal rating scale
Measured: up to 8 days after drug administration
Secondary outcomes (12)
Cmax (maximum concentration of the analyte in plasma)
Measured: up to 32 hours after drug administration
tmax (time from dosing to maximum concentration)
Measured: 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)
Measured: up to 32 hours after drug administration
%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: up to 32 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 32 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 32 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: up to 32 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 32 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 32 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 32 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: 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)
Measured: up to 32 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startApr 2004
- Primary completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256709
- Sponsor's protocol ID
- 1214.1
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect
- ClinicalTrials.gov ID
- NCT02256709
- Acronym / sponsor ID
- 1214.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Aug 2004 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| single rising dose BIBP 5371 CL | Experimental | Drug: BIBP 5371 CL tablet |
| BIBP 5371 CL tablet high dose | Experimental | Drug: BIBP 5371 CL tablet high doseto be compared with same daily dose level from single rising dose arm |
| BIBP 5371 CL tablet low dose | Experimental | Drug: BIBP 5371 CL tablet low doseto be compared with same daily dose level from single rising dose arm |
| Placebo drinking solution | Placebo comparator | Drug: Placebo drinking solution |
| BIBP 5371 CL drinking solution | Experimental | Drug: BIBP 5371 CL solution |
| BIBP 5371 CL tablet high dose with food | Experimental | Other: High fat, high caloric breakfast, Drug: BIBP 5371 CL tablet high dose |
| BIBP 5371 CL tablet low dose with food | Experimental | Other: High fat, high caloric breakfast, Drug: BIBP 5371 CL tablet low dose |
| Placebo tablet | Placebo comparator | Drug: Placebo tablet |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers
- Age 21 - 50 years
- Body mass index (BMI) 18.5 - 29.9 kg/m2
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBP 5371 CL tabletsingle rising daily doses | Drug | single rising dose BIBP 5371 CL |
| BIBP 5371 CL solution | Drug | BIBP 5371 CL drinking solution |
| High fat, high caloric breakfast | Other | BIBP 5371 CL tablet high dose with food, BIBP 5371 CL tablet low dose with food |
| Placebo tablet | Drug | Placebo tablet |
| BIBP 5371 CL tablet high dose | Drug | BIBP 5371 CL tablet high dose, BIBP 5371 CL tablet high dose with food |
| Placebo drinking solution | Drug | Placebo drinking solution |
| BIBP 5371 CL tablet low dose | Drug | BIBP 5371 CL tablet low dose, BIBP 5371 CL tablet low dose with food |
Primary outcome
Number of patients with changes in vital signs
Time frame: baseline, up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, body temperature
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
12 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIBP 5371 CL tablet, BIBP 5371 CL solution and High fat, high caloric breakfast in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with changes in vital signs (time frame: baseline, up to 8 days after drug administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.