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

Primary Purpose

Hypogonadism, Male

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Testosterone Undecanoate
Sponsored by
Clarus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypogonadism, Male

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • Clarus Therapeutics, Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

healthy men treatment arm

Arm Description

Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.

Outcomes

Primary Outcome Measures

measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes
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

rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes
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
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
To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively

Full Information

First Posted
June 2, 2019
Last Updated
July 8, 2019
Sponsor
Clarus Therapeutics, Inc.
Collaborators
Celerion; Syneos Health; ARUP Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT03973840
Brief Title
Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarus Therapeutics, Inc.
Collaborators
Celerion; Syneos Health; ARUP Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy men treatment arm
Arm Type
Experimental
Arm Description
Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.
Intervention Type
Drug
Intervention Name(s)
Testosterone Undecanoate
Intervention Description
dose was given orally and allowed to reach steady state
Primary Outcome Measure Information:
Title
measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes
Description
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
Time Frame
8 days
Secondary Outcome Measure Information:
Title
rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes
Description
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
Time Frame
8 days
Title
magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose
Description
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.
Time Frame
8 days
Title
healthy men's testosterone levels in serum and plasma
Description
To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively
Time Frame
8 days
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events
Description
To characterize the safety and tolerability of JATENZO
Time Frame
8 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects were required to meet all of the following criteria in order to be eligible for the study: 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. 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 Naïve to androgen-replacement therapy Willing to consume the entire protocol-specified breakfast and dinner meals Average screening systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg 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: History of hypertension or taking anti-hypertensive medications 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 Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease 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 History of or was currently being evaluated for breast or prostate cancer Prostate specific antigen above the upper limit of normal 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 Positive urine drug test at the Screening visit 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). Smokers who were unable to refrain from smoking during the confinement period required in this study Current evidence of or history of abuse of alcohol or any drug substance within the previous 2 years Receipt of any drug as part of a research study within 30 days of initial dose administration in this study Blood donation (usually 550 mL) within the 12-week period before the initial study drug dose Hematocrit < 35% or > 50% Body mass index ≥ 31 kg/m2 -
Facility Information:
Facility Name
Clarus Therapeutics, Inc
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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