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AzTrials

HealthyPhase 1NCT02182284

Bioavailability of Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Solution Formulation in Healthy Volunteers

A Phase 1 study testing low dose BI 201335 NA soft gelatine capsule (SGC), high dose BI 201335 NA soft gelatine capsule (SGC) and low dose BI 201335 NA powder in bottle (PIB) 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

The objective of this study was to establish the relative bioavailability of a new soft gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way cross-over study design. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
low dose BI 201335 NA soft gelatine capsule (SGC), high dose BI 201335 NA soft gelatine capsule (SGC) and low dose BI 201335 NA powder in bottle (PIB)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
Jan 2008to Feb 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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
  • Age ≥18 and Age ≤50 years
  • Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Who cannot join

  • Any finding from the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance, as assessed by the investigator
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Show all 24Show fewer
  • Concomitant drugs that in the opinion of the investigator (in consultation with the BI medical monitor or pharmacokinetics), would have interfered with the adsorption, distribution or metabolism of BI 201335
  • Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc (corrected QT interval) interval within 30 days prior to screening until trial completion
  • Use of any investigational drug within 30 days prior to enrolment; or the planned usage of any investigational drug during the course of the current study
  • Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)
  • Inability to abstain from alcohol from Day -14 to day 22
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgement of the investigator
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • Infected with hepatitis A, hepatitis B or hepatitis C viruses (defined as either being hepatitis A antibody positive, hepatitis B surface antigen or HBV DNA positive, or hepatitis C antibody positive)
  • Positive ELISA for HIV-1 (Human immunodeficiency virus) or HIV-2
  • For female subjects:
  • Pregnancy or planning to become pregnant within 2 months of study completion
  • Positive pregnancy test
  • No adequate contraception, e.g. sterilisation, IUD (intrauterine device), have not been using a barrier method of contraception for at least 3 months prior to participation in the study
  • Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
  • Lactation period

About this study

Official title: An Open-label, Randomized, Crossover Relative Bioavailability Study of a New Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Current Solution Formulation (Powder in Bottle (PIB), After Single Dose Oral Administration in Healthy Volunteers

The objective of this study was to establish the relative bioavailability of a new soft gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way cross-over study design.

Conditions
Healthy
Being tested
low dose BI 201335 NA soft gelatine capsule (SGC), high dose BI 201335 NA soft gelatine capsule (SGC), low dose BI 201335 NA powder in bottle (PIB), high dose BI 201335 NA powder in bottle (PIB)

What participants receive

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

  • low dose BI 201335 NA soft gelatine capsule (SGC)Drug

  • high dose BI 201335 NA soft gelatine capsule (SGC)Drug

  • low dose BI 201335 NA powder in bottle (PIB)Drug

  • high dose BI 201335 NA powder in bottle (PIB)Drug

Study groups in NCT02182284
Study groupRoleWhat they receive
BI 201335 NA - low doseExperimentalNot described
Receives: Drug: low dose BI 201335 NA soft gelatine capsule (SGC); Drug: low dose BI 201335 NA powder in bottle (PIB)
BI 201335 NA - high doseExperimentalNot described
Receives: Drug: high dose BI 201335 NA soft gelatine capsule (SGC); Drug: high dose BI 201335 NA powder in bottle (PIB)

What is being measured

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

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

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

  2. Cmax (measured maximum concentration of the analyte in plasma)

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

Secondary outcomes (11)

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

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

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

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

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

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

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

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

  5. λz (terminal elimination rate constant in plasma)

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

  6. MRTpo (mean residence time of the analyte in the body after oral administration)

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

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

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

  8. C24 (measured concentration of the analyte in plasma 24 hours after oral administration)

    Measured: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

  9. Number of patients with clinically significant changes in vital signs

    Measured: Baseline, days 1-6 of each treatment period and day 22

  10. Number of patients with abnormal changes in laboratory parameters

    Measured: Baseline, days 1 and 3-6 of each treatment period and day 22

  11. Number of patients with adverse events

    Measured: up to 29 days

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 startJan 2008
  3. Primary completionFeb 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
Crossover
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182284
Sponsor's protocol ID
1220.10
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 low dose BI 201335 NA soft gelatine capsule (SGC), high dose BI 201335 NA soft gelatine capsule (SGC) and low dose BI 201335 NA powder in bottle (PIB) 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 4 inclusion and 24 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. 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?

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug). The study lists 2 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 NCT02182284.

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.

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