PharmacokineticsPhase 1NCT04729088
Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects
A Phase 1 study testing Isosorbide mononitrate in people with Pharmacokinetics and Healthy Subjects, run by Biolab Sanus Farmaceutica.
Trial summary
This is a Phase I trial to evaluate pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Healthy Subjects
- What is being tested?
- Isosorbide mononitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2020to 20 Dec 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects aged from 18 to 50 years-old;
- Good health conditions or without significant diseases, according to medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory test;
- Ability to understand the nature and objectives of the trial, including risks and adverse events;
- Willingness to proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature;
- Agree to use safe contraceptive method.
Who cannot join
- Known to have hypersensitivity reaction to the studied drug or to chemically related compounds;
- History or presence of chronic gastrointestinal diseases or other condition that may interfere with drug absorption, distribution, metabolism or excretion;
- Maintenance therapy with any drug known to interact with the investigational drug, except contraceptives;
- History of liver, kidney, lung, gastrointestinal, epileptic, haematological or psychiatric disease; hypertension of any etiology; history of myocardial infarction, angina and / or heart failure or malignant neoplasms. Have any current disease, acute or chronic, in follow-up or treatment;
- Have active orificial pathology, such as hemorrhoidal thrombosis, acute or chronic anal fissures, as assessed by the study physician within 15 days from confinement;
- Electrocardiographic findings not recommended at the physician's discretion to participate in the study;
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- History of cardiac (any), renal (renal exeresis or agenesis), gastrointestinal (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid or rectum), liver or pancreas surgery;
- Screening laboratory test results outside normal ranges set by the clinical analysis laboratory, unless considered non-clinically significant by the Principal Investigator / Physician;
- Smoker (more than five cigarettes / day);
- Eating foods containing xanthine, including more than five cups of coffee or tea per day;
- Unusual eating habits, eg vegetarians;
- History of excessive alcohol consumption (drinking 4 or more alcoholic beverages in one day or 8 or more alcoholic beverages per week for women and 5 or more alcoholic beverages in one day or 15 or more alcoholic beverages per week for men);
- History of drug use;
- Use of regular medication within two weeks prior to initiation of treatment and the date of pre-confinement clinical assessment;
- Use of medication containing sildenafil, vardenafil or riociguate, up to 03 days before confinement;
- Use medication containing tadalafil up to 08 days before confinement;
- Use of any medication, except contraceptives or cases where, based on the half-life of the drug and / or active metabolites, complete elimination may be assumed;
- Hospitalization due to any reason up to eight weeks before the start of the trial treatment;
- Treatment with any drug known to have well established toxic potential in the large organs, within three months prior to the study;
- Participation in any other experimental research or administration of any experimental drug within six months prior to the commencement of this trial;
- Pregnancy or breastfeeding or wish to become pregnant during the trial period;
- Donation or loss of 450 mL or more of blood within the three months prior to the trial or donation of more than 1500 mL within the twelve months preceding the trial;
- Any condition that, according to the investigator's best judgement, precludes participation in this trial;
- Inability to lie down, preferably on the side, for 1 hour or as long as necessary at the doctor's discretion;
- Positive test for pregnancy;
- Breathalyzer test result greater than zero;
- Positive result for drug of abuse testing;
- Unavailability for registration on the National Register for Bioequivalence Studies (CNVB)
About this study
Official title: Phase I Clinical Trial to Evaluate the Pharmacokinetic Profile of a Formulation With Isosorbide Mononitrate 0.5% Gel - Manufactured by Sanus Pharmaceutical Ltda, to Intra Anal Application in Healthy Males and Females' Subjects
This is a Phase I trial to evaluate pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration in healthy subjects.
Read the detailed description
This is a Phase I trial to evaluate the pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration. For the current study 2g of a 0,5% gel will be used (as part of a safety investigational profile with doses up to 2% in other studies).
The investigational product will be administered to the participants by the study physician as a single dose. Blood samples will be collected prior dose and up to 36:00 hours to characterize the pharmacokinetic profile.
Safety parameters, including adverse events, will be monitored by the study team during confinement (up to 24 hours post dose), at the 36 hour sample collection (ambulatory basis) and as reported by the subjects or verified at the discharge visit, up to 15 days after dosing.
- Conditions
- Pharmacokinetics, Healthy Subjects
- Being tested
- Isosorbide mononitrate
- Keywords
- Isosorbide Mononitrate, Pharmacokinetics, Intra anal application, Anal Fissure, Healthy volunteers
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide mononitrateDrug
Intra-anal application performed by the study physician of 2 g of the study drug
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | Isosorbide 0.5% gel Receives: Drug: Isosorbide mononitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve from time zero to last (AUC 0-last)
Measured: 36 hours
Area under the plasma concentration versus time curve from time zero to infinite (AUC 0-inf)
Measured: 36 hours
Maximum (peak) plasma concentration (Cmax)
Measured: 36 hours
Time to reach maximum (peak) plasma concentration (Tmax)
Time frame from drug administration to sampling time of maximum plasma concentration
Measured: 36 hours
Elimination rate constant (Ke)
Measured: 36 hours
Half life (t1/2)
Measured: 36 hours
Secondary outcomes (3)
Number of adverse events
Measured: 15 days
Blood Pressure
Blood pressure (Systolic and Diastolic Blood Pressure) pre-dose, at each hour until 12 hours after dose and 24 hours after dose
Measured: 1 day
Pulse
Pulse pre-dose, at each hour until 12 hours after dose and 24 hours after dose
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start20 Dec 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Why it stopped: The sponsor will no longer develop the experimental drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Phase I, single-center, single-dose clinical trial (test drug), in which participants will receive the test drug intra-anal
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Pedrazzoli Jr., MD, Principal investigator, CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729088
- Sponsor's protocol ID
- CAEP 56.003.19PC
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Pharmacokinetic Profile of a Formulation With Isosorbide Mononitrate 0.5% Gel - Manufactured by Sanus Pharmaceutical Ltda, to Intra Anal Application in Healthy Males and Females' Subjects
- ClinicalTrials.gov ID
- NCT04729088
- Acronym / sponsor ID
- CAEP 56.003.19PC
- Conditions
- Pharmacokinetics, Healthy Subjects
- Keywords
- Isosorbide Mononitrate, Pharmacokinetics, Intra anal application, Anal Fissure, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor will no longer develop the experimental drug.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 28 Jan 2021 (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.
This is a Phase I trial to evaluate pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration in healthy subjects.
Detailed description
This is a Phase I trial to evaluate the pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration. For the current study 2g of a 0,5% gel will be used (as part of a safety investigational profile with doses up to 2% in other studies).
The investigational product will be administered to the participants by the study physician as a single dose. Blood samples will be collected prior dose and up to 36:00 hours to characterize the pharmacokinetic profile.
Safety parameters, including adverse events, will be monitored by the study team during confinement (up to 24 hours post dose), at the 36 hour sample collection (ambulatory basis) and as reported by the subjects or verified at the discharge visit, up to 15 days after dosing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, single-center, single-dose clinical trial (test drug), in which participants will receive the test drug intra-anal
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: Isosorbide mononitrateIsosorbide 0.5% gel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects aged from 18 to 50 years-old;
- Good health conditions or without significant diseases, according to medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory test;
- Ability to understand the nature and objectives of the trial, including risks and adverse events;
- Willingness to proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature;
- Agree to use safe contraceptive method.
Key exclusion criteria (28 listed)
- Known to have hypersensitivity reaction to the studied drug or to chemically related compounds;
- History or presence of chronic gastrointestinal diseases or other condition that may interfere with drug absorption, distribution, metabolism or excretion;
- Maintenance therapy with any drug known to interact with the investigational drug, except contraceptives;
- History of liver, kidney, lung, gastrointestinal, epileptic, haematological or psychiatric disease; hypertension of any etiology; history of myocardial infarction, angina and / or heart failure or malignant neoplasms. Have any current disease, acute or chronic, in follow-up or treatment;
- Have active orificial pathology, such as hemorrhoidal thrombosis, acute or chronic anal fissures, as assessed by the study physician within 15 days from confinement;
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 |
|---|---|---|
| Isosorbide mononitrateIntra-anal application performed by the study physician of 2 g of the study drug | Drug | Test Drug |
Primary outcome
Area under the plasma concentration versus time curve from time zero to last (AUC 0-last)
Time frame: 36 hours
Area under the plasma concentration versus time curve from time zero to infinite (AUC 0-inf)
Time frame: 36 hours
Maximum (peak) plasma concentration (Cmax)
Time frame: 36 hours
Time to reach maximum (peak) plasma concentration (Tmax)
Time frame: 36 hours
Time frame from drug administration to sampling time of maximum plasma concentration
Elimination rate constant (Ke)
Time frame: 36 hours
Half life (t1/2)
Time frame: 36 hours
3 secondary outcomes
Number of adverse events
Time frame: 15 days
Blood Pressure
Time frame: 1 day
Pulse
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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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.
José Pedrazzoli Jr., MD principal investigator
CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Isosorbide mononitrate in people with Pharmacokinetics and Healthy Subjects, run by Biolab Sanus Farmaceutica.
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 28 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: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the plasma concentration versus time curve from time zero to last (AUC 0-last) (time frame: 36 hours). The study lists 6 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 1 Feb 2021.