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AzTrials

HealthyPhase 1NCT02259920

Study to Investigate the Regional Drug Absorption of KUC-7483 CL Administered Via an Enterion™ Capsule Compared to an Immediate Release Formulation in Healthy Male Volunteers

A Phase 1 study testing KUC 7483 CL, immediate release tablet, KUC 7483 CL, particulate formulation and KUC 7483 CL, solution formulation 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

Study to determine and compare the absorption of KUC 7483 CL from different regions of the GI tract with the immediate release formulation and to compare the absorption of particulate versus solution formulations from the ascending colon Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
KUC 7483 CL, immediate release tablet, KUC 7483 CL, particulate formulation and KUC 7483 CL, solution formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
No sites listed yet
Study dates
Dec 2003to May 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 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males, 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, clinical laboratory tests
  • No clinically significant findings
  • No evidence of a clinically relevant concomitant disease
  • Age ≥18 and ≤65 years
  • BMI ≥18.5 and ≤29.9 kg/m2
  • Subjects must be able to demonstrate the ability to swallow an empty size 000 gelatin capsule
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Who cannot join

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • History of gastrointestinal surgery, with the exception of Appendicectomy unless it was performed within the previous 12 months
  • Diseases of the central nervous system (such as epilepsy) 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) to any drug including the study drug (KUC-7483 CL) and similar drugs which is deemed relevant to the trial as judged by the investigator
Show all 24Show fewer
  • Use of prescription or non-prescription drugs (including vitamins and natural herbal remedies e.g. St Johns Wort) from 14 days prior to the start of the study until the end of the final study period. Occasional use of paracetamol (up to 4g per day) is permitted throughout the study
  • Participation in another trial with an investigational drug within four months prior to administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day). A breath carbon monoxide reading of greater than 20ppm
  • Inability to refrain from smoking on trial days
  • Regular alcohol consumption >21 units per week units per week (1 Unit = ½ pint beer, a 25ml shot of 40% spirit or a 125ml glass of wine)
  • Subjects who have ever sought advice from a physician or counselor for abuse or misuse of alcohol, non-medicinal drugs or other substances of abuse e.g. solvents
  • Any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide, and amphetamines (Class B).
  • Volunteers who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months
  • Positive drugs of abuse result
  • Blood donation (more than 100 mL within three months prior to administration or during the trial)
  • Excessive physical activities outside a subjects normal routine (within one week prior to administration or during the trial until after the post-study medical)
  • Unable to eat all elements of a standard meal
  • Any laboratory value outside the reference range of clinical relevance as determined by the Investigator
  • Radiation exposure from clinical trials, including that from the present study and from diagnostic X-rays but excluding background radiation, exceeding 5mSv in the last twelve months or 10mSv in the last five years. No subject whose occupational exposure is monitored will participate in the study
  • Acute diarrhea, or constipation in the 14 days before the predicted first study day. If screening occurs >14 days before first study day, this criterion is to be determined on first study day. Diarrhea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
  • Presence of non-removable metal objects such as metal plates, screws etc. in abdominal region of the body
  • Subjects will be excluded from the study if they are considered by the investigator to be at risk of transmitting through blood and other body fluids the agents responsible for AIDS (Acquired Immunodeficiency Syndrome) or other sexually transmitted disease or hepatitis. This will be achieved by the use of a card (similar to that used by the National Blood Transfusion Service) which asks a potential subject if they have reason to believe that they may fall into any category included on the card. If the verbal answer is in the affirmative then they will be excluded from the study
  • Positive hepatitis B virus, hepatitis C virus or HIV results

About this study

Official title: Open Label, Randomized, Single-dose, Five-way Crossover Study to Investigate the Regional Drug Absorption of 80 mg KUC-7483 CL Administered Via an Enterion™ Capsule Compared to an Immediate Release Formulation in Healthy Male Volunteers.

Study to determine and compare the absorption of KUC 7483 CL from different regions of the GI tract with the immediate release formulation and to compare the absorption of particulate versus solution formulations from the ascending colon

Conditions
Healthy
Being tested
KUC 7483 CL, immediate release tablet, KUC 7483 CL, particulate formulation, KUC 7483 CL, solution formulation, Enterion™ capsule

What participants receive

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

  • KUC 7483 CL, immediate release tabletDrug

  • KUC 7483 CL, particulate formulationDrug

  • KUC 7483 CL, solution formulationDrug

  • Enterion™ capsuleDevice

Study groups in NCT02259920
Study groupRoleWhat they receive
Treatment AActive comparatorKUC 4783 CL, immediate release tablets
Receives: Drug: KUC 7483 CL, immediate release tablet
Treatment BExperimentalKUC 4783 CL delivered as a particulate formulation to the distal small bowel
Receives: Drug: KUC 7483 CL, particulate formulation; Device: Enterion™ capsule
Treatment CExperimentalKUC 4783 CL delivered as a particulate formulation to the ascending colon
Receives: Drug: KUC 7483 CL, particulate formulation; Device: Enterion™ capsule
Treatment DExperimentalKUC 4783 CL delivered as a solution formulation to the ascending colon
Receives: Drug: KUC 7483 CL, solution formulation; Device: Enterion™ capsule
Treatment EExperimentalKUC 4783 CL delivered as a solution formulation to the descending colon
Receives: Drug: KUC 7483 CL, solution formulation; Device: Enterion™ capsule

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: up to 24 hours after drug administration

Secondary outcomes (12)

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

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

  3. 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: up to 24 hours after drug administration

  4. λz (terminal rate constant of the analyte constant in plasma)

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

  7. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

  10. fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2)

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

  12. Number of subjects with adverse events

    Measured: up to 8 days after last drug administration

Timeline

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

  1. First posted9 Oct 2014 (estimated)
  2. Study startDec 2003
  3. Primary completionMay 2004

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02259920
Sponsor's protocol ID
1207.2
Status last verified
Oct 2014
First submitted
7 Oct 2014
Last updated
9 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KUC 7483 CL, immediate release tablet, KUC 7483 CL, particulate formulation and KUC 7483 CL, solution formulation 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 8 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 9 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?

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 24 hours after drug administration). 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 NCT02259920.

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 9 Oct 2014.

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