Hypogonadism
Conditions
Keywords
Paediatric
Brief summary
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.
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.
Interventions
DRUGTestosterone Nasal Gel [Natesto]
nasal gel containing 4.5% w/w testosterone
Sponsors
Acerus Biopharma Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
dual arm: naïve vs TRT experienced
Eligibility
Sex/Gender
MALE
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study: 1. Hypogonadal boys; 2. Chronological age 12 to \<18 years; 3. No prior exposure to TRT; 4. Prepubertal 5. 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: 1. Hypogonadal boys with a bone age of ≥13 years (a historical value within the last 12 months will be acceptable); 2. Chronological age 12 to \<18 years; 3. Taking an existing TRT treatment dose; 4. Tanner Stage ≥3 5. 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: 1. Any active allergic condition or presentation of symptoms including allergic rhinitis; 2. An upper respiratory tract infection; 3. 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; 4. In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness; 5. 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; 6. 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; 7. History of severe adverse drug reactions to testosterone therapies; 8. Current treatment with other androgens (e.g., dehydroepiandrosterone \[DHEA\]), anabolic steroids, or other sex hormones; 9. Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within the previous 12 months; 10. Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone; 11. Diabetes mellitus; 12. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed