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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02222558
Other study ID # TT-006
Secondary ID
Status Completed
Phase Phase 2
First received August 18, 2014
Last updated May 21, 2015
Start date September 2014
Est. completion date April 2015

Study information

Verified date May 2015
Source TesoRx Pharma, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.


Description:

The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date April 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),

- 18-70 years old,

- Willing and able to provide informed consent and to participate in all 3 periods of the study.

- BMI < 35 kg/m2.

Exclusion Criteria:

- Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);

- Alcoholics or substance abuse;

- Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;

- Congestive Heart Failure, uncontrolled (NYHC >1);

- Uncontrolled sleep apnea;

- Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;

- Testopel excluded if within 2 years;

- Aveed excluded if within past 6 months;

- Hematocrit > 50.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
TSX-002
TSX-002 are capsules with testosterone as the active ingredient.

Locations

Country Name City State
United States San Diego Sexual Medicine San Diego California

Sponsors (1)

Lead Sponsor Collaborator
TesoRx Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Testosterone Total (actual measured) Testosterone, AUC(0-t) (where AUC is area under curve and t = 8, 12 and 24 hours), Cmax, Tmax, Cmin, tmin and Cmax to Cmin ratio.
Baseline Corrected Testosterone: kel, t½, CL/F, Vss/F, AUC(0-t(last)) and AUC(0-8).
Participants will be followed for the duration the study, an expected average of 9 weeks No
Secondary Serum dihydrotestosterone (DHT) AUC, Cmax, Tmax, Cmax, Cmin, Cavg, Tmax, Tmin, Participants will be followed for the duration the study, an expected average of 9 weeks No
Secondary Safety of TSX-002 clinically significant changes in laboratory parameters
physical examinations,
frequency and severity of adverse events
standard 12-lead ECG parameters and vital signs assessments
adverse events leading to discontinuation of study drug
Participants will be followed for the duration the study, an expected average of 9 weeks Yes
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