Evaluation of Testosterone Nasal Gel in Hypogonadal Boys
Study Details
Study Description
Brief Summary
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
ARM 1 - 10 prepubertal, 12-17 years old boys with no prior exposure to TRT will receive single dose of 5.5 mg on day one and single dose of 11 mg on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.
ARM 2 - 10 Tanner Stage 3, 12-17 years old boys on TRT with bone age >= 13 years will receive single dose of 11 mg on day one, and single dose of 11 mg in the morning and a second 11 mg dose in the afternoon on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naive patients - ARM 1 TRT naïve subjects, Tanner Stage of 0, receiving Testosterone Nasal Gel [Natesto] - Single dose of 5.5 mg Natesto on Day 1 and a single dose of 11 mg Natesto on Day 2 |
Drug: Testosterone Nasal Gel [Natesto]
nasal gel containing 4.5% w/w testosterone
|
| Experimental: Non-naive patients - ARM 2 TRT non-naïve subjects (have had prior testosterone treatment), Tanner Stage >/= 3, receiving Testosterone Nasal Gel [Natesto] - Single dose of 11 mg Natesto on Day 1. On Day 2, 11 mg dose of Natesto in the morning and 11 mg dose of Natesto 12 hours later |
Drug: Testosterone Nasal Gel [Natesto]
nasal gel containing 4.5% w/w testosterone
|
Outcome Measures
Primary Outcome Measures
- Maximum plasma concentration (Cmax) [48 hours (approx)]
Cmax for serum testosterone, serum DHT and serum estradiol
- Area under the curve (AUC) [48 hours (approx)]
AUC for serum testosterone, serum DHT and serum estradiol
- Minimum serum concentration (Cmin) [48 hours (approx)]
Cmin for serum testosterone, serum DHT and serum estradiol
- Time to reach maximum plasma concentration (tmax) [48 hours (approx)]
tmax for serum testosterone, serum DHT and serum estradiol
Secondary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events (Safety) [5 days]
Safety assessments will include adverse events, clinical laboratory measurements of serum testosterone, DHT and estradiol levels, and vital sign measurements. A phone call will be made 3 days after the patient leaves the clinic to collect any SAEs or AEs that may occur.
- Incidence of Treatment-Emergent Adverse Events (Tolerability) [48 hours (approx)]
To include a adverse events that relate to tolerability and a patient and healthcare provider questionnaire on ease of use dispenser and gel administration
Eligibility Criteria
Criteria
Inclusion Criteria:
ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
-
Hypogonadal boys;
-
Chronological age 12 to <18 years;
-
No prior exposure to TRT;
-
Prepubertal
-
Parent/guardian and patient able to understand and provide signed informed consent;
ARM 2 (non-naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
-
Hypogonadal boys with a bone age of ≥13 years (a historical value within the last 12 months will be acceptable);
-
Chronological age 12 to <18 years;
-
Taking an existing TRT treatment dose;
-
Tanner Stage ≥3
-
Parent/guardian and patient able to understand and provide signed informed consent;
Exclusion Criteria:
ARM 1 (naïve patients) AND ARM 2 (non-naïve patients): Participants who meet any of the following criteria will be excluded from participation in the study:
-
Any active allergic condition or presentation of symptoms including allergic rhinitis;
-
An upper respiratory tract infection;
-
Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants, within the last 3 months;
-
In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;
-
History of pituitary or hypothalamic tumors or history of any malignancy excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery;
-
History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically Sjogren's syndrome;
-
History of severe adverse drug reactions to testosterone therapies;
-
Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones;
-
Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within the previous 12 months;
-
Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;
-
Diabetes mellitus;
-
Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Glasgow, Royal Hospital for Children | Glasgow | Scotland | United Kingdom | G51 4TF |
| 2 | Cambridge University Hospital's NHS Foundation Trust | Cambridge | United Kingdom | CB2 0QQ | |
| 3 | Alder Hey Children's Hospital | Liverpool | United Kingdom | L14 5AB |
Sponsors and Collaborators
- Acerus Biopharma Inc.
Investigators
- Principal Investigator: Syed Faisal Ahmed, MD, Royal Hospital for Children, U. of Glasgow
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NAT-2017-01