Healthy VolunteersPhase 1HMNCT04081376
Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control
A Phase 1 study testing Hydromorphone Hydrochloride in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hydromorphone Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2019to 18 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Having taken medication regularly in the month prior to the study sessions. Treatment with monoamine oxidase inhibitors (MAOIs), buprenorphine, nalbuphine or pentazocine during the two months prior to the study. Treatment with single doses of another type of symptomatic medication in the week prior to the study sessions will not be a reason for exclusion if it is assumed that the drug has been completely eliminated on the day of the experimental session.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Hydromorphone Hydrochloride
- Keywords
- Hydromorphone, Opiates, Anti-doping control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone HydrochlorideDrug
4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone) administered orally in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Hydromorphone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-1 urine samples
Measured: 0-4 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-2 urine samples
Measured: 4-8 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-3 urine samples
Measured: 8-12 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-4 urine samples
Measured: 12-24 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-5 urine samples
Measured: 24-36 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-6 urine samples
Measured: 36-48 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-7 urine samples
Measured: 48-60 hours post-administration
Urine concentration of hydromorphone
Concentration of hydromorphone in fraction-8 urine samples
Measured: 60-72 hours post-administration
Secondary outcomes (8)
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-1 urine samples
Measured: 0-4 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-2 urine samples
Measured: 4-8 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-3 urine samples
Measured: 8-12 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-4 urine samples
Measured: 12-24 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-5 urine samples
Measured: 24-36 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-6 urine samples
Measured: 36-48 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-7 urine samples
Measured: 48-60 hours post-administration
Urine concentration of hydromorphone metabolites
Concentration of different hydromorphone metabolites in fraction-8 urine samples
Measured: 60-72 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start20 Nov 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There is one single treatment group (HM), and no control group.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana M Aldea Perona, Dr, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081376
- Sponsor's protocol ID
- IMIMFTCL/HM
- Acronym
- HM
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control
- ClinicalTrials.gov ID
- NCT04081376
- Acronym / sponsor ID
- HM / IMIMFTCL/HM
- Conditions
- Healthy Volunteers
- Keywords
- Hydromorphone, Opiates, Anti-doping control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is one single treatment group (HM), and no control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Hydromorphone HydrochlorideSubjects 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone Hydrochloride4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone) administered orally in a single dose. | Drug | Treatment group |
Primary outcome
Urine concentration of hydromorphone
Time frame: 0-4 hours post-administration
Concentration of hydromorphone in fraction-1 urine samples
Urine concentration of hydromorphone
Time frame: 4-8 hours post-administration
Concentration of hydromorphone in fraction-2 urine samples
Urine concentration of hydromorphone
Time frame: 8-12 hours post-administration
Concentration of hydromorphone in fraction-3 urine samples
Urine concentration of hydromorphone
Time frame: 12-24 hours post-administration
Concentration of hydromorphone in fraction-4 urine samples
Urine concentration of hydromorphone
Time frame: 24-36 hours post-administration
Concentration of hydromorphone in fraction-5 urine samples
Urine concentration of hydromorphone
Time frame: 36-48 hours post-administration
Concentration of hydromorphone in fraction-6 urine samples
Urine concentration of hydromorphone
Time frame: 48-60 hours post-administration
Concentration of hydromorphone in fraction-7 urine samples
Urine concentration of hydromorphone
Time frame: 60-72 hours post-administration
Concentration of hydromorphone in fraction-8 urine samples
8 secondary outcomes
Urine concentration of hydromorphone metabolites
Time frame: 0-4 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 4-8 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 8-12 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 12-24 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 24-36 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 36-48 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 48-60 hours post-administration
Urine concentration of hydromorphone metabolites
Time frame: 60-72 hours post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M Aldea Perona, Dr principal investigator
IMIM (Hospital del Mar Medical Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydromorphone Hydrochloride in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine concentration of hydromorphone (time frame: 0-4 hours post-administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.