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Bioavailability of KD025 in Healthy Male Subjects Completed in the UK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557139
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
Bioavailability, Phase I study to evaluate the clinical performance of the tablet formulation in the fasted and fed states, in comparison to the capsule formulation in the fed state.

Condition or disease Intervention/treatment Phase
Bioavailability Drug: KD025 Tablet Drug: KD025 as drug in capsule Phase 1

Detailed Description:
A 200 mg tablet formulation of KD025 is being developed at Quotient Clinical to replace the capsule formulation. This Phase I study will evaluate the clinical performance of the tablet formulation in the fasted and fed states, in comparison to the capsule formulation in the fed state.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Three Way Crossover, Randomised, Open-Label Study in Healthy Subjects, Designed to Compare the Bioavailability of a KD025 Tablet Formulation Administered in the Fed and Fasted States and to Assess the Relative Bioavailability of a Tablet and Capsule Formulation in the Fed State
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Regimen A
200 mg KD025 tablet in the fasted state
Drug: KD025 Tablet
Other Name: SLx-2119

Experimental: Regimen B
200 mg KD025 tablet in the fed state
Drug: KD025 Tablet
Other Name: SLx-2119

Experimental: Regimen C
200 mg KD025 as drug in capsule in the fed state
Drug: KD025 as drug in capsule
Other Name: SLx-2119




Primary Outcome Measures :
  1. Lag Time (Tlag) of KD025 tablet formulation [ Time Frame: 1 month ]
    Tlag will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  2. Time of Maximum Concentration (Tmax) of KD025 tablet formulation [ Time Frame: 1 month ]
    Tmax will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  3. Peak plasma concentration of a drug after administration (Cmax) of KD025 tablet formulation [ Time Frame: 1 month ]
    Cmax will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  4. Area Under the Concentration Curve 0-24 hours (AUC (0-24)) of KD025 tablet formulation [ Time Frame: 1 month ]
    AUC (0-24) will be evaluated by comparing of KD025 tablet formulation in the fed and fasted states

  5. AUC 0 to last dose (0-last) of KD025 tablet formulation [ Time Frame: 1 month ]
    AUC (0-last) will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  6. AUC from 0 to infinity (0-inf) of KD025 tablet formulation [ Time Frame: 1 month ]
    AUC (0-inf) will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  7. AUC percentage extrapolating (AUC%extrap) of KD025 tablet formulation [ Time Frame: 1 month ]
    AUC(%extrap) will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  8. Individual estimate of the terminal elimination rate constant (Lambda-z) of KD025 tablet formulation in fed and fasted states [ Time Frame: 1 month ]
    Lambda-z will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  9. Terminal Elimination Half-Life Time (T1/2) of KD025 tablet formulation [ Time Frame: 1 month ]
    T1/2 will be evaluated by comparing KD025 tablet formulation in the fed and fasted states

  10. Mean Residence Time (MRT) of KD025 tablet formulation in fed and fasted states [ Time Frame: 1 month ]
    MRT will be evaluated by comparing of KD025 tablet formulation in the fed and fasted states


Secondary Outcome Measures :
  1. Determine the effect of a high fat meal on the bioavailability of KD025 tablet formulation [ Time Frame: 1 month ]
    Bioavailability will be determined by comparing and assessing the AUC of KD025 tablet to capsule with a high fat meal

  2. Determine the effect of a high fat meal on the bioavailability of KD025 tablet formulation [ Time Frame: 1 month ]
    Bioavailability will be determined by comparing and assessing the Cmax of KD025 tablet to capsule with a high fat meal

  3. Bioavailability of KD025 in Healthy Volunteers [ Time Frame: 1 month ]
    Bioavailability will be determined by comparing and assessing the AUC of KD025 tablet to capsule.

  4. Bioavailability of KD025 in Healthy Volunteers [ Time Frame: 1 month ]
    Bioavailability will be determined by comparing and assessing the Cmax of KD025 tablet to capsule.

  5. Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 month ]
    To provide additional safety and tolerability information for KD025



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index 18.0 to 30.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  • Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG and laboratory investigations (hematology, coagulation, clinical chemistry and urinalysis)
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • Must agree to use an adequate method of contraception for up to 90 days post discharge

Exclusion Criteria:

  • Participation in a clinical research study within the previous 3 months
  • Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  • Subjects who have previously been enrolled in this study
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  • Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator
  • Positive drugs of abuse test result or alcohol breath test
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • History of any clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease that may compromise the subject safety or interfere with the objectives of the study as judged by the investigator
  • Subject has a history or presence of any of the following:

    1. Active GI disease requiring therapy
    2. Hepatic disease and/or ALT or AST >1.5 × ULN at screening
    3. Renal disease and/or serum creatinine >1.5 × ULN at screening
    4. Other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • Subject has QT interval corrected using Fridericia's formula (QTcF) intervals >450 msec at the screening or admission ECG
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Subject has a known sensitivity to ROCK2 inhibitor agents or to any of the constituents of the KD025 formulation
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration
  • Failure to satisfy the investigator of fitness to participate for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557139


Locations
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United Kingdom
Quotient Clinical Limited
Ruddington Nottingham, United Kingdom, NG116JS
Sponsors and Collaborators
Kadmon Corporation, LLC
Quotient Clinical
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Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02557139    
Other Study ID Numbers: KD025-106
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: November 2015