Healthy Volunteers Clinical Trial
Official title:
Generation of Biological Samples Positive to Triptorelin for Anti-doping Control
Background:
Androgens are used for doping purpose because they can increase muscle mass and strength.
These drugs are included in the list of prohibited substances of the World Anti-Doping Agency
(WADA). The prohibition of its use has given rise to a great variety of strategies of
indirect androgenic doping, whose purpose is to produce a sustained increase in endogenous
testosterone.
Triptorelin acetate is a gonadotropin-releasing hormone (GnRH) agonist. Daily subcutaneous
administration of triptorelin causes an initial increase in circulating levels of luteinizing
hormone (LH) and follicle stimulating hormone (FSH), producing a transient increase in
testosterone levels. However, prolonged daily administration results in a paradoxical
decrease in LH and FSH levels due to desensitization of GnRH receptors, decreasing
testosterone production to levels similar to castration.
Thus, the initial flare reaction produced by triptorelin administration could be used by
athletes as an indirect androgenic doping method to stimulate the synthesis of endogenous LH
and testosterone with the aim of improving physical performance.
Hypothesis:
Subcutaneous administration of triptorelin in healthy subjects allows obtaining positive
urine samples that will be used to identify analytical strategies for doping detection.
Triptorelin concentrations and its metabolites can be measured in urine.
Objectives:
Primary objective: To measure triptorelin concentrations in urine samples for anti-doping
control.
Secondary objectives: To identify triptorelin metabolites in urine. To explore the time
window in which the drug or its metabolites can be detected in urine after administration.
Methods:
Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition
(triptorelin) administered subcutaneously in a single dose to 2 subjects.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
| Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
| Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
| Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
| Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
| Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
| Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
| Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
| Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
| Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
| Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
| Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
| Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
| Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |