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

NCT03973840 | Completed Phase 1 FDA Drug

• 1 other identifier: CLAR-18019
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

• 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

  8 days

Secondary Outcomes (3)

• rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes

  8 days

• magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose

  8 days

• healthy men's testosterone levels in serum and plasma

  8 days

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  8 days

Study Arms (1)

healthy men treatment arm

EXPERIMENTAL

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

Interventions

Testosterone Undecanoate DRUG

dose was given orally and allowed to reach steady state

healthy men treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Clarus Therapeutics, Inc.: lead
• Celerion; Syneos Health; ARUP Laboratories: collaborator

Study Sites (1)

Clarus Therapeutics, Inc

Northbrook, Illinois, 60062, United States

Location

MeSH Terms

Conditions

Eunuchism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: July 15, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)