Phlebotomy Study of Testosterone Undecanoate

• Sponsor: Clarus Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02670343
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: Oral Testosterone Undecanoate	Phase 1/Phase 2

Detailed Description

This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral Testosterone Undecanoate A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.	Drug: Oral Testosterone Undecanoate; Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.; Other Names: testosterone undecanoate

Outcome Measures

Primary Outcome Measures

1. % of Mean Difference in T Concentration Compared to Plain Collection Tube [Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.]

   The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube. The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.

2. Adequate venous access to allow blood sample collections via venous cannula.

3. Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study.

4. Voluntarily provide written informed consent to participate in this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will not be eligible:

1. Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)

2. Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.

3. BMI less than 18 kg/m2 or greater than 37 kg/m2

4. Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.

5. History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures.

6. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.

7. Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.

8. Parenteral T-undecanoate therapy within the past 6 months.

9. Use of dietary supplements that may increase serum T, within previous 4 weeks.

10. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.

11. Smokers unable to refrain from smoking during required confinement period.

12. History of, or current evidence of, abuse of alcohol or any drug substance.

13. Receipt of any research study drug within 30 days of study.

14. Blood donation within the 12 week period before the initial study dose.

15. Hematocrit less than 35% or greater than 50%.

16. History of clinically significant polycythemia following treatment with a testosterone replacement product.

17. Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.

18. History of uncontrolled sleep apnea.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles Biomedical Research Institute	Torrance	California	United States	90502

Sponsors and Collaborators

• Clarus Therapeutics, Inc.

Investigators

• Principal Investigator: Christina Wang, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clarus Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02670343
• Other Study ID Numbers: CLAR-15013
• First Posted: Feb 1, 2016
• Last Update Posted: Mar 9, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Hypogonadism; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

Participant Flow

Arm/Group Title	Oral Testosterone Undecanoate
Arm/Group Description	A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject. Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Oral Testosterone Undecanoate
Arm/Group Description	A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject. Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.3 (11.60)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	8 100%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	% of Mean Difference in T Concentration Compared to Plain Collection Tube
Description	The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube. The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.
Time Frame	Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Testosterone Undecanoate
Arm/Group Description	A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject. Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Measure Participants	8
NAF+EDTA	8.6 (18.3)
NAF+Oxalate	16.6 (18.5)
NAF	23.2 (20.9)

Adverse Events

Time Frame	2 months
Adverse Event Reporting Description	All adverse events whether causally related to treatment or not are recorded beginning with date of information consent (prior to treatment) and for 7 days following last dose of study drug. Observation period lasted 2 months
Arm/Group Title	Oral Testosterone Undecanoate
Arm/Group Description	A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject. Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
All Cause Mortality
	Oral Testosterone Undecanoate
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Oral Testosterone Undecanoate
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Oral Testosterone Undecanoate
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.