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

NCT04081376 | Completed Phase 1

• 1 other identifier: IMIMFTCL/HM
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Hydromorphone; Opiates; Anti-doping control

Outcome Measures

Primary Outcomes (8)

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-1 urine samples

  0-4 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-2 urine samples

  4-8 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-3 urine samples

  8-12 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-4 urine samples

  12-24 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-5 urine samples

  24-36 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-6 urine samples

  36-48 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-7 urine samples

  48-60 hours post-administration

• Urine concentration of hydromorphone

  Concentration of hydromorphone in fraction-8 urine samples

  60-72 hours post-administration

Secondary Outcomes (8)

• Urine concentration of hydromorphone metabolites

  0-4 hours post-administration

• Urine concentration of hydromorphone metabolites

  4-8 hours post-administration

• Urine concentration of hydromorphone metabolites

  8-12 hours post-administration

• Urine concentration of hydromorphone metabolites

  12-24 hours post-administration

• Urine concentration of hydromorphone metabolites

  24-36 hours post-administration

Study Arms (1)

Treatment group

EXPERIMENTAL

Subjects receive a single-dose treatment.Urine samples will be collected after administration (8 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-60h, 60-72h post-administration).

Drug: Hydromorphone Hydrochloride

Interventions

Hydromorphone Hydrochloride DRUG

4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone) administered orally in a single dose.

Treatment group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male volunteers aged between 18 and 45 years.
• Able to understand and accept the trial procedures and able to sign an informed consent.
• History and physical examination that demonstrate not presenting organic or psychiatric disorders.
• ECG, blood and urine tests performed before the test within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified sin writing.
• Body mass index (weight/height\^2) between 19 and 25 kg/m2. BMI between 25 and 27 kg/m2 may be included according to Principal Investigator's criteria.

You may not qualify if:

• History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or similar nonapeptides, or to any of the excipients.
• Patients who have undergone surgical interventions and/or have had underlying diseases that could lead to a stricture of the gastrointestinal tract, that have "blind handles" of the gastrointestinal tract or gastrointestinal obstruction.
• Patients with severe decrease in liver function.
• Patients with respiratory failure or history of asthma crisis.
• Patients with acute abdominal pain of unknown origin.
• Background or clinical evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.
• Background or clinical evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
• Having participated in another clinical trial with medication in the three months prior to the start of the study.
• Having suffered some organic disease or major surgery in the six months prior to the start of the study.
• Antecedents or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may pose a risk to the subjects or may interfere with the objectives of the study. Especially epileptic seizures or a history of epilepsy.
• Smokers of more than 20 cigarettes a day in the 3 months before the study.
• Consumption of more than 20 g of alcohol daily in women and more than 40 g in men.
• Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the study start.
• Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
• Positive serology for hepatitis B, C or HIV.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

IMIM (Hospital del Mar Medical Research Institute)

Barcelona, 08003, Spain

Location

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ana M Aldea Perona, Dr

  IMIM (Hospital del Mar Medical Research Institute)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is one single treatment group (HM), and no control group.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: November 20, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)