The purpose of this study is to demonstrate the effectiveness of the multiple dose dispenser in comparison to the syringe as measured by a testsoterone pharmacokinetic profile
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare a pharmacokinetic profile of testosterone after administration of
TBS-1 from two different dispensing devices by measuring:
• Cmin, Cmax, and tmax for the 12 hour interval.
• AUC0-12, and Cavg.
• The relative pharmacokinetic profile of the pre-filled syringe and the
multiple dose dispenser will be determined using the AUC0-12h and Cmax0-12h
corrected for the endogenous serum testosterone concentration. The relative
mean of the dispenser to the pre-filled syringe using log transformed data for
AUC0-12h and Cmax0-12h corrected for the endogenous serum testosterone
concentration, should be between 80% to 125%.
Secondary outcome
Safety
• Vital Signs (Blood Pressure, Body Temperature, Respiratory Rate, Heart Rate).
• Physical and otorhinolaryngological examination.
• Complete Blood Count.
• Clinical chemistry profile
• Urinalysis.
Background summary
Trimel BioPharma has developed an intranasal testosterone gel (TBS-1) as a
hormone replacement therapy for the treatment of male hypogonadism. The nasal
mucosa offers an alternative route of administration that is not subjected to
the first pass metabolism, has high permeability, with rapid absorption into
the systemic circulation, producing high plasma levels similar to those
observed after intravenous administration. The advantages of the testosterone
intranasal gel when compared to other formulations include ease of
administration and no transference of testosterone to other family members.
Trimel has identified a multiple dose dispenser that is intended as the
commercial device . To date, a syringe has been used to deliver TBS-1 in the
previous clinical trials. The purpose of this study is to demonstrate the
effectiveness of the multiple dose dispenser in comparison to the syringe.
Study objective
The purpose of this study is to demonstrate the effectiveness of the multiple
dose dispenser in comparison to the syringe as measured by a testsoterone
pharmacokinetic profile
Study design
This will be an open label, balanced, randomized, crossover, two-group,
two-treatment, two-period, pharmacokinetic study of testosterone nasal gel
formulation in healthy, adult, male human subjects.
Intervention
TBS-1 testosterone nasal gel administered using a dispenser or syringe.
Study burden and risks
The risk to the subject participating in this study is considered to be
minimal. Testosterone replacement therapy is indicated for the treatment of
hypogonadism. TBS-1 has been administered to over 100 men with minimal side
effects. Participants may find the nasal endoscopy and numerous blood draws
unpleasant.
There is no direct benefit to subjects participating in this study as they are
normal healthy men. Subjects will be financially compensated for their
participation.
Suite B, Durants Business Centre Durant,
Christ church BB17097
AU
Suite B, Durants Business Centre Durant,
Christ church BB17097
AU
Listed location countries
Age
Inclusion criteria
1. Healthy male human subjects within the age range of 18 to 45 years inclusive
2. Willingness to provide written informed consent to participate in the study
3. Body-mass index of less than or equal to 35 kg/m2
4. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during screening
5. Normal otorhinolaryngological examination
6. Non-smokers for at least six months
7. Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol
Exclusion criteria
1. Personal / family history of allergy or hypersensitivity to testosterone or related drugs
2. Past history of anaphylaxis or angioedema
3. Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
5. Hemoglobin < 13g/dl and Hematocrit > 52% during screening
6. Any cardiac, renal or liver impairment, any other organ or system impairment
7. History of seizure or psychiatric disorders
8. Presence of disease markers for HIV 1 and/or 2, Hepatitis B and/or C virus
9. History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, (*nose job*), or sinus surgery
10. Subject with prior nasal fractures
11. Subject with active allergies, such as rhinitis, rhinorrhea, or nasal congestion
12. Subject with mucosal inflammatory disorders, specifically pemphigus, or Sjogren*s syndrome
13. Subject with sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis
14. History of nasal disorders (e.g. polyposis, recurrent epistaxis (> 1 nose bleed per month), abuse of nasal decongestants) or sleep apnea
15. Subject using any form of intranasal medication delivery, specifically nasal corticosteroids and oxymetazoline containing nasal sprays (e.g. Dristan 12-Hour Nasal Spray)
16. History of asthma and/ or on-going asthma treatment
17. Regular drinkers of more than three (3) units of alcohol daily (1 unit = 300 ml beer, 1 glass wine, 1 measure spirit), or consumption of alcohol within 48 hours prior to dosing and during the study.
18. Volunteer demonstrating a positive test for alcohol consumption (using breath alcohol analyzer) at the time of check-in during the admission periods.
19. History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
20. Volunteers demonstrating a positive test for drugs of abuse in urine (Opiates, Benzodiazepines, Amphetamines, THC and cocaine) at the time of check-in during admission periods
21. Inaccessibility of veins in left and right arm
22. Receipt of any prescription drug therapy within four weeks of the first admission period.
23. Difficulty in abstaining from OTC medication (except occasional paracetamol/aspirin) for the duration of the study
24. Volunteers demonstrating serum PSA >= 4ng/ml
25. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
26. Blood donation (usually 550 ml) at any time during this study, or within the 12 week period before the start of this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-000179-14-NL |
| CCMO | NL35420.056.11 |