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Trial record 85 of 79996 for:    subjects

Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group

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ClinicalTrials.gov Identifier: NCT01901133
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief Summary:

This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects.

The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and age-matched subjects with normal hepatic function.


Condition or disease Intervention/treatment Phase
Pharmacokinetics of MDV3100 Healthy Subjects Kidney Diseases Drug: MDV3100 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MDV3100 in Male Subjects With Mild or Moderate Hepatic Impairment and Normal Hepatic Function
Study Start Date : October 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A: Mild hepatic impairment subjects + control Drug: MDV3100
Oral
Other Names:
  • Xtandi
  • enzalutamide

Experimental: B: Moderate hepatic impairment subjects + control Drug: MDV3100
Oral
Other Names:
  • Xtandi
  • enzalutamide




Primary Outcome Measures :
  1. Assessment of pharmacokinetics measured by AUC0-inf following single dose of MDV3100 [ Time Frame: Day 1 through Day 50 (25 times) ]
    Area under the plasma concentration - time curve extrapolated to infinity (AUC0-inf) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.

  2. Assessment of pharmacokinetics measured by Cmax following single dose of MDV3100 [ Time Frame: Day 1 through Day 50 (25 times) ]
    Maximum concentration (observed) (Cmax) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.


Secondary Outcome Measures :
  1. Composite of pharmacokinetics following single dose of MDV3100 [ Time Frame: Day 1 through Day 50 (25 times) ]
    Measured by Time to attain Cmax (tmax), AUC up to last quantifiable concentration (AUC0-last), Apparent terminal elimination half life (t1/2), Apparent volume of distribution during the terminal phase after extra vascular dosing (Vz/F), Apparent total body clearance after extra vascular dosing (CL/F), Cmax, t1/2, AUC0-inf, Unbound maximum concentration (observed) (Cmax,u), Unbound AUC extrapolated to infinity (AUC0-inf,u), Unbound apparent total body clearance after extra vascular dosing (CLu/F), Unbound apparent volume of distribution during the terminal phase after extra vascular dosing (Vz,u/F), Fraction unbound (fu).

  2. Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG) and clinical safety laboratory and adverse events [ Time Frame: Day 1 through Day 50 ]
    For hepatic impaired subjects, additional Child-Pugh classification will be performed after MDV3100 administration.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects must meet all of the following inclusion criteria:

    • Subject must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies
    • Body Mass Index (BMI) of at least 18.5 and no greater than 34.0 kg/m2.
  • Subjects with mild or moderate hepatic impairment must also meet the following inclusion criteria:

    • Child-Pugh classification Class A (mild, 5 or 6 points) or Class B (moderate, 7 to 9 points) liver function impairment.

Exclusion Criteria:

  • All subjects must not have any of the following characteristics:

    • Known or suspected hypersensitivity to MDV3100 or any components of the formulation used.
    • History of seizure or any condition that may predispose to seizure. Also history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit).
    • Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
    • Abnormal pulse and/or blood pressure (BP) measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic BP >160 mmHg; mean diastolic BP >100 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured
    • A QTcF interval of >450 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
    • Significant renal dysfunction (creatinine clearance below 60 mL/min, estimated according to the method of modification of diet in renal disease (MDRD) formula).
    • Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
    • Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life.
  • For subjects with normal hepatic function:

    • Regular use of any prescribed or OTC (over-the-counter) drugs, which includes vitamins, natural and herbal remedies (e.g. St John's wort) and food supplements in the 4 weeks prior to admission to the Clinical Unit and use of any drugs in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day).
    • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV, anti-HIV-1 or anti-HIV-2.
  • For subjects with mild or moderate hepatic impairment:

    • Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period. (e.g. advanced ascites, infection of ascites, fever, active gastrointestinal bleeding).
    • Change in dose regimen of medically required medication within the last two weeks before pre-study examination (allowed co-medication in patients), and/or the use of unallowed co-medication in the 3 weeks prior to admission to the clinical unit (not allowed: any known hepatic enzyme altering agents or compounds known to restrict metabolism).
    • Presence of a hepatocellular carcinoma, or an acute liver disease caused by an infection or drug toxicity.
    • Severe portal hypertension or surgical porto-systemic shunts, including TIPSS (Transjugular intrahepatic portosystemic shunt).
    • Biliary obstruction or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
    • Signs of significant hepatic encephalopathy (Hepatic encephalopathy score >2).
    • Severe ascites and/or pleural effusion
    • Esophageal variceal bleeding in the medical history.
    • Thrombocyte level below 40x109/L and /or hemoglobin below 90 g/L.
    • Previous liver transplantation.
    • Positive serology test for, anti HAV (IgM), anti-HIV-1 or anti-HIV-2.

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): NCT01901133


Locations
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Moldova, Republic of
Arensia
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Medivation, Inc.
Investigators
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Study Chair: Operation Senior Research Manager Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01901133     History of Changes
Other Study ID Numbers: 9785-CL-0009
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Phase 1
MDV3100
Hepatic Impairment
Kidney Diseases
Xtandi
enzalutamide

Additional relevant MeSH terms:
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Kidney Diseases
Liver Diseases
Urologic Diseases
Digestive System Diseases