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出境医 / 临床实验 / Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

Study Description
Brief Summary:
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Drug: Testosterone Undecanoate Phase 1

Detailed Description:
This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures [room temperature or on ice] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes
Actual Study Start Date : July 15, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: healthy men treatment arm
Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.
 Drug: Testosterone Undecanoate
dose was given orally and allowed to reach steady state
Outcome Measures
Primary Outcome Measures :
  1. measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes [ Time Frame: 8 days ]
    To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation


Secondary Outcome Measures :
  1. rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes [ Time Frame: 8 days ]
    To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA tubes held at room temperature or on ice prior to centrifugation

  2. magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose [ Time Frame: 8 days ]
    To estimate the magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose, when blood was collected in various tubes and the tubes were held at room temperature or on ice.

  3. healthy men's testosterone levels in serum and plasma [ Time Frame: 8 days ]
    To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8 days ]
    To characterize the safety and tolerability of JATENZO


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects were required to meet all of the following criteria in order to be eligible for the study:

  1. Male (gender at birth) 18 to 65 years of age, inclusive, and legally able to give informed consent, as applicable by law. The percentage of non-Hispanic and Hispanic men was specified to be approximately ≥ 70% and ≤ 30%, respectively.
  2. Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula or needle sticks
  3. Naïve to androgen-replacement therapy
  4. Willing to consume the entire protocol-specified breakfast and dinner meals
  5. Average screening systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg
  6. Voluntarily gave written informed consent to participate in this study -

Exclusion Criteria:

Subjects who met any of the following criteria were not eligible for participation in this study:

  1. History of hypertension or taking anti-hypertensive medications
  2. Intercurrent disease deemed clinically significant, in the opinion of the Investigator, of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including congestive heart failure, coronary heart disease, heart attack or cerebrovascular accident in prior 6 months, or psychiatric-illness, including severe depression
  3. Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal
  4. Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease
  5. Current use of the following groups of drugs that affect testosterone levels, testosterone metabolism, or levels of testosterone metabolites, namely antiandrogens, 5 alpha reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride), or human growth hormone
  6. History of or was currently being evaluated for breast or prostate cancer
  7. Prostate specific antigen above the upper limit of normal
  8. Positive test for antibodies to human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or antibodies to hepatitis C virus at the Screening visit
  9. Positive urine drug test at the Screening visit
  10. Current treatment with oral lipase inhibitors (eg, orlistat [Xenical]), bile acid-binding resins (eg, cholestyramine [Questran], colestipol [Colestid]), fibric acid derivatives (eg, clofibrate [Atromid-X], gemfibrozil [Lopid]), and probucol (Lorelco).
  11. Smokers who were unable to refrain from smoking during the confinement period required in this study
  12. Current evidence of or history of abuse of alcohol or any drug substance within the previous 2 years
  13. Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
  14. Blood donation (usually 550 mL) within the 12-week period before the initial study drug dose
  15. Hematocrit < 35% or > 50%
  16. Body mass index ≥ 31 kg/m2 -
Contacts and Locations

Locations
Layout table for location information
United States, Illinois
Clarus Therapeutics, Inc
Northbrook, Illinois, United States, 60062
Sponsors and Collaborators
Clarus Therapeutics, Inc.
Celerion; Syneos Health; ARUP Laboratories
Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE July 15, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes [ Time Frame: 8 days ]
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		Primary Objective [ Time Frame: 8 days ]
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes [ Time Frame: 8 days ]
    To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA tubes held at room temperature or on ice prior to centrifugation
  • magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose [ Time Frame: 8 days ]
    To estimate the magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose, when blood was collected in various tubes and the tubes were held at room temperature or on ice.
  • healthy men's testosterone levels in serum and plasma [ Time Frame: 8 days ]
    To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Secondary objective 1 [ Time Frame: 8 days ]
    • To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA tubes held at room temperature or on ice prior to centrifugation
  • Secondary objective 2 [ Time Frame: 8 days ]
    • To estimate the magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose, when blood was collected in various tubes and the tubes were held at room temperature or on ice.
  • Secondary objective 3 [ Time Frame: 8 days ]
    • To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively
Current Other Pre-specified Outcome Measures
 (submitted: June 25, 2019) 		Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8 days ]
To characterize the safety and tolerability of JATENZO
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
Official Title  ICMJE A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes
Brief Summary To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
Detailed Description This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures [room temperature or on ice] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hypogonadism, Male
Intervention  ICMJE Drug: Testosterone Undecanoate
dose was given orally and allowed to reach steady state
Study Arms  ICMJE Experimental: healthy men treatment arm
Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.
Intervention: Drug: Testosterone Undecanoate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2019) 		13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects were required to meet all of the following criteria in order to be eligible for the study:

  1. Male (gender at birth) 18 to 65 years of age, inclusive, and legally able to give informed consent, as applicable by law. The percentage of non-Hispanic and Hispanic men was specified to be approximately ≥ 70% and ≤ 30%, respectively.
  2. Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula or needle sticks
  3. Naïve to androgen-replacement therapy
  4. Willing to consume the entire protocol-specified breakfast and dinner meals
  5. Average screening systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg
  6. Voluntarily gave written informed consent to participate in this study -

Exclusion Criteria:

Subjects who met any of the following criteria were not eligible for participation in this study:

  1. History of hypertension or taking anti-hypertensive medications
  2. Intercurrent disease deemed clinically significant, in the opinion of the Investigator, of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including congestive heart failure, coronary heart disease, heart attack or cerebrovascular accident in prior 6 months, or psychiatric-illness, including severe depression
  3. Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal
  4. Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease
  5. Current use of the following groups of drugs that affect testosterone levels, testosterone metabolism, or levels of testosterone metabolites, namely antiandrogens, 5 alpha reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride), or human growth hormone
  6. History of or was currently being evaluated for breast or prostate cancer
  7. Prostate specific antigen above the upper limit of normal
  8. Positive test for antibodies to human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or antibodies to hepatitis C virus at the Screening visit
  9. Positive urine drug test at the Screening visit
  10. Current treatment with oral lipase inhibitors (eg, orlistat [Xenical]), bile acid-binding resins (eg, cholestyramine [Questran], colestipol [Colestid]), fibric acid derivatives (eg, clofibrate [Atromid-X], gemfibrozil [Lopid]), and probucol (Lorelco).
  11. Smokers who were unable to refrain from smoking during the confinement period required in this study
  12. Current evidence of or history of abuse of alcohol or any drug substance within the previous 2 years
  13. Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
  14. Blood donation (usually 550 mL) within the 12-week period before the initial study drug dose
  15. Hematocrit < 35% or > 50%
  16. Body mass index ≥ 31 kg/m2 -
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973840
Other Study ID Numbers  ICMJE CLAR-18019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clarus Therapeutics, Inc.
Study Sponsor  ICMJE Clarus Therapeutics, Inc.
Collaborators  ICMJE Celerion; Syneos Health; ARUP Laboratories
Investigators  ICMJE Not Provided
PRS Account Clarus Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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