Oral Testosterone for the Treatment of Hypogonadism

NCT01717768 | Completed Phase 2 Results

• 1 other identifier: TT-002
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. The purpose of this study is to evaluate the ability of TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days. In addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. Related Outcome Measures will be reported for Parts 1, 2, and 4. A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported for Part 3.

Conditions

Hypogonadism

Keywords

hypogonadism; Gonadal Disorders; Endocrine System Diseases; Testosterone; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Therapeutic Uses; Anabolic Agents

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002

  Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.

  15 days

Secondary Outcomes (1)

• Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment

  15 days

Other Outcomes (2)

• Cavg 0-24 Hrs (ng/dL) After 120 mg Dose

  24 hrs

• AUC 0-24 Hrs After 120 mg Dose of TSX-002

  24 hrs

Study Arms (10)

Part 1: 120 mg BID

EXPERIMENTAL

Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days

Drug: TSX-002

Part 1: 240 mg BID

EXPERIMENTAL

Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days

Drug: TSX-002

Part 2: 120 mg BID

EXPERIMENTAL

Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days

Drug: TSX-002

Part 3: A-B-C 120 mg QD

EXPERIMENTAL

Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C. * Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing. * Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing. * Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

Drug: TSX-002

Part 3: B-C-A 120 mg QD

EXPERIMENTAL

Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C. * Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing. * Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing. * Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

Drug: TSX-002

Part 3: C-A-B 120 mg QD

EXPERIMENTAL

Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C. * Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing. * Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing. * Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

Drug: TSX-002

Part 4 Cohort 1: 60 mg BID/ 60 mg TID

EXPERIMENTAL

Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days

Drug: TSX-002

Part 4 Cohort 2: 90 mg BID/ 90 mg TID

EXPERIMENTAL

Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days

Drug: TSX-002

Part 4 Cohort 3: 180 mg QD

EXPERIMENTAL

Oral TSX-002 180 mg once daily (QD) for 15 days

Drug: TSX-002

Part 4 Cohort 4: 120 mg BID

EXPERIMENTAL

Oral TSX-002 120 mg BID for 15 days

Drug: TSX-002

Interventions

TSX-002 DRUG

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

Also known as: Testosterone

Part 1: 120 mg BID; Part 1: 240 mg BID; Part 2: 120 mg BID; Part 3: A-B-C 120 mg QD; Part 3: B-C-A 120 mg QD; Part 3: C-A-B 120 mg QD; Part 4 Cohort 1: 60 mg BID/ 60 mg TID; Part 4 Cohort 2: 90 mg BID/ 90 mg TID; Part 4 Cohort 3: 180 mg QD; Part 4 Cohort 4: 120 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone \< 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
• Men over the age of 18 years with a body mass index (BMI) \< 39.0 kg/m2 and weighing ≥ 55 kg
• Hemoglobin levels at screening and baseline \> 12.5 g/dL
• Testosterone treatment not contraindicated
• No evidence of suspected reversible hypogonadism
• Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
• Understands the requirements of the study and voluntarily consents to participate in the study

Sponsors & Collaborators

• TesoRx Pharma, LLC: lead

Study Sites (1)

Urology Group of Southern California

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Michael Oefelein, MD, Chief Medical Officer
• Organization: TesoRx Pharma LLC

karl@tesorx.com

909-595-0500

Study Officials

• John Kowalczyk, DO, FACOS

  Urology Group of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-12

Locations

US (1)