AzTrials
AzTrials

HealthyPhase 1NCT02182297

Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects

A Phase 1 study testing BI 201335 NA in single rising doses 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
Search all trials

Trial summary

The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers. Read more about this study

Who is it for?
Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 201335 NA in single rising doses
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
No sites listed yet
Study dates
Apr 2008to Dec 2008
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 20 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects will be healthy male volunteers who meet the criteria below:
  • Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
  • Persons who are 20 or older and 35 or younger
  • Persons with body mass index (BMI) of 18.5 kg/m2 or more and 25.0 kg/m2 less
  • Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with the GCP (Good Clinical Practice)

Who cannot join

  • Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • Prior history of jaundice
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Show all 22Show fewer
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • 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 prior to administration or during the trial
  • Use of any drugs within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational product within four months prior to administration or during the trial
  • Smoker (>10 cigarettes, >3 cigars or >3 pipes/day)
  • Inability to refrain from smoking on trial days (during hospitalisation and end of trial)
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
  • Excessive physical activities (within 1 week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of the trial site
  • A history of additional risk factors for torsades de pointe (e.g., heart failure, hypokalemia, and family history of long QT syndrome)
  • The use of concomitant medications that prolong the QT/corrected QT interval

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses (40 mg to 480 mg) of BI 201335 NA as Capsule(s) Administered to Healthy Male Subjects - a Randomised, Placebo-controlled (Within Dose Groups) and Double-blind Trial

The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers.

Conditions
Healthy
Being tested
BI 201335 NA in single rising doses, Placebo

What participants receive

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

  • BI 201335 NA in single rising dosesDrug

  • PlaceboDrug

Study groups in NCT02182297
Study groupRoleWhat they receive
BI 201335 NA in single rising dosesExperimentalNot described
Receives: Drug: BI 201335 NA in single rising doses
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Number of patients with abnormal findings in physical examination

    Measured: Baseline and within 7 days after last trial procedure

  2. Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)

    Measured: Baseline, pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose and day 12

  3. Number of patients with abnormal findings in 12-lead electrocardiography (ECG)

    Measured: Baseline, pre-dose and 1, 2, 4, 6, 8, 24, 48, 72 and 96 hours post-dose and day 12

  4. Number of patients with abnormal changes in laboratory tests (haematology, clinical chemistry, and urinalysis)

    Measured: Baseline, pre-dose and 24, 48, 72 and 96 hours post-dose and day 12

  5. Number of patients with adverse events

    Measured: up to day 12

  6. Assessment of tolerability by the investigator on a 4-point scale

    Measured: day 12 (within 7 days after last trial procedure)

Secondary outcomes (12)

  1. Cmax (maximum concentration of the analyte in plasma)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  2. tmax (time from dosing to maximum concentration of the analyte in plasma)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

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

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  4. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  5. λz (terminal elimination rate constant in plasma)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  6. t1/2 (terminal half-life of the analyte in plasma)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  7. MRTpo (mean residence time of the analyte in the body after po administration)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  8. CL/F (apparent clearance of the analyte in the plasma after oral administration)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  9. Vz/F (apparent volume of distribution during the terminal phase λz following an oral administration)

    Measured: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  10. Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)

    Measured: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose

  11. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)

    Measured: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose

  12. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)

    Measured: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose

Timeline

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

  1. First posted8 Jul 2014 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2008

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
Parallel groups
Masking
Double blind
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182297
Sponsor's protocol ID
1220.13
Status last verified
Jul 2014
First submitted
2 Jul 2014
Last updated
18 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 201335 NA in single rising doses 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 5 inclusion and 22 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 18 Jul 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 abnormal findings in physical examination (time frame: Baseline and within 7 days after last trial procedure). 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 NCT02182297.

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 18 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in