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Clinical Trials/NL-OMON36214
NL-OMON36214CompletedNot Applicable

A phase-I open label, balanced, randomized, crossover, two-groups, two-treatments, two-period, pilot study in healthy male subjects to determine the feasibility of a multiple dose dispenser for testosterone intranasal gel as measured by pharmacokinetics - Testosterone nasal gel using dispenser or syringe in healthy volunteers

Trimel Biopharma SR0 sites12 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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.

Investigators

Sponsor
Trimel Biopharma SR

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