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Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

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ClinicalTrials.gov Identifier: NCT03345797
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation ( Acerus Biopharma Inc. )

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
Hypogonadism Drug: Testosterone Nasal Gel [Natesto] 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: dual arm: naïve vs TRT experienced
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter, Open Label, Variable Dose, Two Arm Pilot Paediatric Phase 1 PK Study to Evaluate Testosterone Nasal Gel (4.5% w/w) in Hypogonadal Boys
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 48 hours (approx) ]
    Cmax for serum testosterone, serum DHT and serum estradiol

  2. Area under the curve (AUC) [ Time Frame: 48 hours (approx) ]
    AUC for serum testosterone, serum DHT and serum estradiol

  3. Minimum serum concentration (Cmin) [ Time Frame: 48 hours (approx) ]
    Cmin for serum testosterone, serum DHT and serum estradiol

  4. Time to reach maximum plasma concentration (tmax) [ Time Frame: 48 hours (approx) ]
    tmax for serum testosterone, serum DHT and serum estradiol


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: 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.

  2. Incidence of Treatment-Emergent Adverse Events (Tolerability) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   hypogonadal boys
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345797


Contacts
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Contact: Matthew Gronski, Ph.D. 289-334-1461 mgronski@aceruspharma.com
Contact: Nathan Bryson, Ph.D. 416-679-0776 nbryson@aceruspharma.com

Locations
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United Kingdom
University of Glasgow, Royal Hospital for Children Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Faisal S Ahmed, MD    +44 141 451 5841    Faisal.Ahmed@glasgow.ac.uk   
Principal Investigator: Faisal S Ahmed, MD         
Cambridge University Hospital's NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Carlo Acerini, MD    +44 1223 336865    cla22@cam.ac.uk   
Principal Investigator: Carlo L Acerini, MD         
Alder Hey Children's Hospital Not yet recruiting
Liverpool, United Kingdom, L14 5AB
Principal Investigator: Dan Hawcutt         
Sponsors and Collaborators
Acerus Biopharma Inc.
Investigators
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Principal Investigator: Syed Faisal Ahmed, MD Royal Hospital for Children, U. of Glasgow

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Responsible Party: Acerus Biopharma Inc.
ClinicalTrials.gov Identifier: NCT03345797     History of Changes
Other Study ID Numbers: NAT-2017-01
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acerus Pharmaceuticals Corporation ( Acerus Biopharma Inc. ):
Paediatric

Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents