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HealthyPhase 1NCT02264197

Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects

A Phase 1 study testing BIBX 245 CL - fed and BIBX 245 CL- fasted in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BIBX 245 CL - fed and BIBX 245 CL- fasted
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
No sites listed yet
Study dates
May 1998to Jun 1998
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 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Age >= 18 and <= 50 years
  • Broca >= -20% and <= +20%

Who cannot join

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
Show all 17Show fewer
  • 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) (<= 1 month prior to administration or during the trial)
  • Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (<= 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 study days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial)
  • Excessive physical activities (<= 10 days prior to administration or during the trial)
  • Any laboratory value outside the reference range or clinical relevance

About this study

Official title: Single-dose Pharmacokinetics of 160 mg BIBX 245 CL and Effect of Food After Oral Administration of Tablets to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety

Conditions
Healthy
Being tested
BIBX 245 CL - fed, BIBX 245 CL- fasted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIBX 245 CL - fedDrug

  • BIBX 245 CL- fastedDrug

Study groups in NCT02264197
Study groupRoleWhat they receive
BIBX 245 CL - fedExperimentalafter a light breakfast with 40 g fat
Receives: Drug: BIBX 245 CL - fed
BIBX 245 CL - fastedActive comparatorNot described
Receives: Drug: BIBX 245 CL- fasted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax (Maximum measured concentration of the analyte in plasma)

    Measured: up to 24 hours post dose

  2. AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Measured: up to 24 hours post dose

  3. tmax (Time from dosing to the maximum concentration of the analyte in plasma)

    Measured: up to 24 hours post dose

  4. λz (Terminal rate constant in plasma)

    Measured: up to 24 hours post dose

  5. t½ (Terminal half-life of the analyte in plasma)

    Measured: up to 24 hours post dose

  6. MRTtot (Mean residence time)

    Measured: up to 24 hours post dose

Secondary outcomes (2)

  1. Number of subjects with adverse events

    Measured: up to 20 days

  2. Assessment of tolerability by investigator

    Measured: after 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startMay 1998
  3. Primary completionJun 1998

Resources

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
Crossover
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264197
Sponsor's protocol ID
537.7
Status last verified
Oct 2014
First submitted
14 Oct 2014
Last updated
15 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBX 245 CL - fed and BIBX 245 CL- fasted 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 17 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 15 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. 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?

Cmax (Maximum measured concentration of the analyte in plasma) (time frame: up to 24 hours post dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264197.

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 15 Oct 2014.

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