A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

Study Overview
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Brief Summary
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This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application

Official Title
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A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application

Conditions
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Hypogonadal Males

Intervention / Treatment
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* Drug: Testosterone Gel (FE 999303)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-75 History of hypogonadism In good health based on medical history, physical examination, and clinical laboratory tests Serum testosterone deficiency One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning) Body mass index (BMI) between 18 and 35 kg/m^2 All screening lab tests within 20% of the normal range (exceptions are liver function tests) HIV, Hepatitis B and C negative Exclusion Criteria: Previous use of FE 999303 Prostate cancer Breast carcinoma, patient or partner Palpable prostatic mass(es) Serum PSA levels ≥3 ng/dL Chronic use of any drug of abuse Lower urinary tract obstruction Clinically significant anemia or renal dysfunction Cardiovascular disease Hyperparathyroidism or uncontrolled diabetes Generalized skin irritation or significant skin disease Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone) Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening) Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations) Sleep apnea Untreated depression Subject with a partner who is pregnant or will not use contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone 2.50 mL (hand)<br>Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. | Drug: Testosterone Gel (FE 999303)<br> <br> |
| Experimental: Testosterone 1.25 mL (applicator)<br>Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days. | Drug: Testosterone Gel (FE 999303)<br> <br> |
| Experimental: Testosterone 2.50 mL (applicator)<br>Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. | Drug: Testosterone Gel (FE 999303)<br> <br> |
| Experimental: Testosterone 3.75 mL (applicator)<br>Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days. | Drug: Testosterone Gel (FE 999303)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | Descriptive statistics was used to present the outcome results. | Days 15-21, Days 22-28 & Days 29-35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand. |  | Days 1-7 | 
| Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Cavg |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator | 
| Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Tmax |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Cmax |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Cavg |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Cmin |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand | 
| Pharmacokinetics of Total Testosterone and DHT Measuring Tmin |  | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |