NCT04081376

Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Background: Hydromorphone (HM) is a semi-synthetic derivative of morphine used for pain control. Like other opiates, due to its high potential of abuse HM is included on the World Anti-Doping Agency (WADA) list of prohibited substances. Hypothesis: The oral administration of hydromorphone hydrochloride in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control. Objectives: Primary objective: To measure the concentrations of hydromorphone in urine for anti-doping control samples. Secondary objective: To identify metabolites and precursors of hydromorphone in urine. To assess safety and tolerability of the drug used. Methods: Phase I, open, non-randomized clinical trial, with a treatment condition (hydromorphone) administered orally to 2 subjects.

Detailed description

This study aims to characterize the patterns of urinary excretion of HM following the oral administration of 4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone). The detection of HM consumption can be done by urine immunoassay but several immunoassay tests are required to thoroughly detect synthetic, semi-synthetic and natural opioids due to the limited cross-reactivity of each assay. Therefore, superior test strategies are required to specifically identify low concentrations of opioids.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Hydromorphone Hydrochloride	4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone) administered orally in a single dose.

Timeline

• Start date: 2019-11-20
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2019-09-09
• Last updated: 2019-12-23

Locations

1 site across 1 country: Spain