Erectile DysfunctionPhase 1FM58NCT04008732
Evaluating MED2005 & Nitrostat Bioavailability
A Phase 1 study testing MED2005, Nitrostat 0.6Mg Sublingual Tablet and Nitro Pohl in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 1 site in United Kingdom.
Trial summary
Futura Medical Developments Ltd (FMD) are developing a gel formulation of GTN (MED2005) as a topical treatment for ED delivered using DermaSys®, a versatile and bespoke technology. Treatment requires the application of a small quantity of gel (approx 300 mg), containing a fixed dose of GTN, to the glans of the penis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- MED2005, Nitrostat 0.6Mg Sublingual Tablet and Nitro Pohl
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2017to 16 Apr 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 50 years of age, inclusive (at screening).
- A BMI of 18.5-30 kg/m2 (inclusive).
- No clinical significant abnormal serum biochemistry, haematology and urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test may be repeated on admission at the discretion of the Investigator.
- Negative HIV and Hepatitis B and C results.
- No clinically significant abnormalities in 12-lead ECG as defined by the Investigator.
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- No clinically significant deviation outside the normal ranges for blood pressure and heart rate measurements as defined by the Investigator (please refer to appendix 1 for normal ranges).
- Subjects (unless anatomically sterile (documented evidence) or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use 2 effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral contraceptive + condom.
- Intra-uterine device (IUD) + condom.
- Diaphragm with spermicide + condom.
- Subjects must be available to complete all periods of the study and the follow-up visit.
- Subjects must satisfy the PI / designee about their fitness to participate in the study.
- Subjects must be able to read and understand the informed consent form and must provide written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption (Part 1 only).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days (or 5 half-lives (whichever is longer) prior to the first dose of IMP, unless in the opinion of the Investigator and Sponsor's Responsible Physician the medication will not interfere with the study procedures or compose subject safety.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of drug or alcohol abuse within 2 years before the first dose of IMP.
- A clinically significant history of previous allergy/sensitivity to GTN, other nitrates and/or any of the excipients in either the test of reference products.
- Recent history of using PDE5 inhibitors or alkyl nitrates (e.g. poppers).
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- A history of frequent tension headaches or vascular headaches or migraine.
- A history of increased intra-cranial pressure or spinal cord injury.
- A history of severe psychological disorders.
- A presence of scarring/piercings/tattoos at the site of MED2005 administration (penis) (or any other features that the Investigator considers may influence IMP absorption).
- Subjects (if uncircumcised) who are not able to retract foreskin of penis easily without any discomfort.
- Any obvious sensitivity/local tolerability issues at the site of medication application.
- Inability to communicate well with the investigator (i.e. language problems, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity or marketed drug clinical study within the previous 3 months or, five half-lives of study drug, whichever is the longer period. (NB. the three month washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Subjects who smoke (or ex-smokers) who have smoked or used nicotine-containing products (including snuff, chewing tobacco, cigars, pipes or nicotine replacement products) within four months prior to first dose.
- Donation or receipt of ≥ 450 mL of blood within 3 months before the first dose of IMP.
- Donation of sperm from the first dose and for at least 3 months after the last dose of IMP.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Limited
Merthyr Tydfil, Wales, CF48 4DR
About this study
Official title: A Single Centre, Open-label, Randomised, Single Dose, Six Period, Reference Replicate, Crossover Study to Evaluate the Bioavailability of MED2005
Futura Medical Developments Ltd (FMD) are developing a gel formulation of GTN (MED2005) as a topical treatment for ED delivered using DermaSys®, a versatile and bespoke technology. Treatment requires the application of a small quantity of gel (approx 300 mg), containing a fixed dose of GTN, to the glans of the penis. Pharmacokinetic studies in healthy volunteers indicate rapid absorption of the drug and low systemic exposure, reducing the risk of adverse events (such as headache) commonly associated with GTN therapy.
The purpose of this study is to demonstrate similar or lower bioavailability of GTN from MED2005 (test IMP) with that from Nitrostat (reference IMP).
Read more
The study will be conducted in two parts (Part 1 and 2). Part 1 will be conducted in 30 subjects and Part 2 will be conducted in 10 subjects. Part 1 will compose of a pre-study screen, followed by six treatment periods and a post-study follow-up.
Part 2 will compose of a pre-study screen, followed by two treatment periods and a post-study follow-up. Subjects can only participate in either Part 1 or 2 of the study (not both).
Read the detailed description
GTN is a well-established vasodilatory therapeutic agent with a long, documented history of use and comprehensive safety profile. In Europe, licensed indications for GTN include the treatment and prophylaxis of angina pectoris and the relief of pain associated with chronic anal fissure. Other indications for prescription only parenteral products include use during cardiac surgery and for emergency reduction of blood pressure.
GTN's vasodilatory action is thought to result from the release of nitric oxide (NO) in vascular smooth muscle. NO stimulates guanylate cyclase, the enzyme responsible for production of cGMP, whose action is to lower intracellular calcium resulting in smooth muscle relaxation and vasodilation.
In the case of erectile dysfunction, GTN works locally by penetrating the glans/penile skin and directly targeting penile blood vessels. Nitrates appear to have a direct, local effect on penile haemodynamics. The most likely mechanism for the erectile effect of nitrates involves nitrate induced dilation of the cavernous and helicine arteries, thereby increasing blood flow to the lacunar spaces, coupled with nitrate-induced relaxation of trabecular smooth muscle.
Nitroglycerin (Nitrostat) is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of postcapillary vessels, including large veins, promotes peripheral pooling of blood, decreases venous return to the heart, and reduces left ventricular end-diastolic pressure (preload). Nitroglycerin also produces arteriolar relaxation, thereby reducing peripheral vascular resistance and arterial pressure (afterload), and dilates large epicardial coronary arteries; however, the extent to which this latter effect contributes to the relief of exertional angina is unclear.
Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.
- Conditions
- Erectile Dysfunction
- Being tested
- MED2005, Nitrostat 0.6Mg Sublingual Tablet, Nitro Pohl
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED2005Drug
Also called glyceryl trinitrate
(Day -1 to Day 1): Subjects will undergo six treatment periods, each separated by at least a two day washout. Each treatment period will be approximately 1 day in duration from the afternoon of Day -1 to the afternoon of Day 1 at 6 hours (h) post-dose. In each of the treatment periods, the subject will receive one of the six administrations over 6 treatment periods (1/period) and will return approximately two days later for the next treatment period.
Nitrostat 0.6Mg Sublingual TabletDrug
Also called Nitroglycerin 0.6 mg
Active comparator to be used for Part 1 of the study. Nitrostat will be dosed in two treatment periods and 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose.
Nitro PohlDrug
Also called Nitroglycerin
to be dosed intravenously in Part 2 of the study
| Study group | Role | What they receive |
|---|---|---|
| MED2005 (0.6 mg) | Experimental | MED2005 (0.2% GTN) gel to be used topically in Part 1 of the study Receives: Drug: MED2005; Drug: Nitrostat 0.6Mg Sublingual Tablet |
| MED2005 (1.2 mg) | Experimental | MED2005 (0.4% GTN) gel to be used topically in Part 1 of the study Receives: Drug: MED2005; Drug: Nitrostat 0.6Mg Sublingual Tablet |
| MED2005 (1.8 mg) | Experimental | MED2005 (0.6% GTN) gel to be used topically in Part 1 of the study Receives: Drug: MED2005; Drug: Nitrostat 0.6Mg Sublingual Tablet |
| Nitrostat (1.8 mg) - Treatment Period 1 | Active comparator | 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose to be used orally in Part 1 of the study but to be dosed in two treatment periods Receives: Drug: MED2005; Drug: Nitrostat 0.6Mg Sublingual Tablet |
| Nitrostat (1.8 mg) - Treatment Period 2 | Active comparator | 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose to be used orally in Part 1 of the study but to be dosed in two treatment periods Receives: Drug: MED2005; Drug: Nitrostat 0.6Mg Sublingual Tablet |
| MED2005 (2.4 mg)- Part 1 | Experimental | MED2005 (0.8% GTN) gel to be used topically in Part 1 of the study Receives: Drug: MED2005; Drug: Nitrostat 0.6Mg Sublingual Tablet |
| Intravenous (I.V.) dose of GTN (0.3 mg) | Active comparator | GTN solution for infusion (1 mg/ml) to be used intravenously in Part 2 of the study Receives: Drug: Nitro Pohl |
| MED2005 (2.4 mg)- Part 2 | Experimental | MED2005 (0.8% GTN) gel to be used topically in Part 2 of the study Receives: Drug: Nitro Pohl |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of AUC0-t (Part 1)
The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN
Measured: 22 days
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of AUC0-inf (Part1)
The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN
Measured: 22 days
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of Cmax (part1)
The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN
Measured: 22 days
Secondary outcomes (5)
The pharmacokinetics of GTN metabolite 1,2-GDN will be evaluated following the administration of MED2005 compared with Nitrostat (Part 1).
The percentage of drug metabolites in the bloodstream following administration of MED2005 (test formulation) with Nitrostat (reference) (part 1) will be compared and evaluated.
Measured: 22 days
Adverse events (AEs) coded using Medical Dictionary for Regulatory Activities (MedDRA) version 20.0 or higher
The incidence of treatment-emergent AEs (TEAE) will be summarised by organ system, preferred term, severity and relationship to study drug. AEs will be identified via abnormal vital signs, abnormal 12-lead ECG parameters, and/or abnormal laboratory safety data
Measured: 46 days
GTN absorption (to quantify the amount of GTN remaining on the glans penis post application)
To quantify the amount of GTN remaining on the glans penis post application of MED2005 (Part 2).
Measured: 10 days
GTN absorption (to quantify a figure of 100% GTN being absorbed)
I.V. dosing to quantify a figure of 100% GTN being absorbed (Part 2).
Measured: 10 days
The pharmacokinetics of GTN metabolite1,3-GDN will be evaluated following the administration of MED2005 compared with Nitrostat (Part 1).
the percentage of drug metabolites in the bloodstream following administration of MED2005 (test formulation) with Nitrostat (reference) (part 1) will be compared and evaluated.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Nov 2017
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Futura Medical Developments Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Israel, Israel, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008732
- Sponsor's protocol ID
- FM58
- Acronym
- FM58
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Open-label, Randomised, Single Dose, Six Period, Reference Replicate, Crossover Study to Evaluate the Bioavailability of MED2005
- ClinicalTrials.gov ID
- NCT04008732
- Acronym / sponsor ID
- FM58 / FM58
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Futura Medical Developments Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 5 Jul 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.
Futura Medical Developments Ltd (FMD) are developing a gel formulation of GTN (MED2005) as a topical treatment for ED delivered using DermaSys®, a versatile and bespoke technology. Treatment requires the application of a small quantity of gel (approx 300 mg), containing a fixed dose of GTN, to the glans of the penis. Pharmacokinetic studies in healthy volunteers indicate rapid absorption of the drug and low systemic exposure, reducing the risk of adverse events (such as headache) commonly associated with GTN therapy.
The purpose of this study is to demonstrate similar or lower bioavailability of GTN from MED2005 (test IMP) with that from Nitrostat (reference IMP).
The study will be conducted in two parts (Part 1 and 2). Part 1 will be conducted in 30 subjects and Part 2 will be conducted in 10 subjects. Part 1 will compose of a pre-study screen, followed by six treatment periods and a post-study follow-up.
Part 2 will compose of a pre-study screen, followed by two treatment periods and a post-study follow-up. Subjects can only participate in either Part 1 or 2 of the study (not both).
Detailed description
GTN is a well-established vasodilatory therapeutic agent with a long, documented history of use and comprehensive safety profile. In Europe, licensed indications for GTN include the treatment and prophylaxis of angina pectoris and the relief of pain associated with chronic anal fissure. Other indications for prescription only parenteral products include use during cardiac surgery and for emergency reduction of blood pressure.
GTN's vasodilatory action is thought to result from the release of nitric oxide (NO) in vascular smooth muscle. NO stimulates guanylate cyclase, the enzyme responsible for production of cGMP, whose action is to lower intracellular calcium resulting in smooth muscle relaxation and vasodilation.
In the case of erectile dysfunction, GTN works locally by penetrating the glans/penile skin and directly targeting penile blood vessels. Nitrates appear to have a direct, local effect on penile haemodynamics. The most likely mechanism for the erectile effect of nitrates involves nitrate induced dilation of the cavernous and helicine arteries, thereby increasing blood flow to the lacunar spaces, coupled with nitrate-induced relaxation of trabecular smooth muscle.
Nitroglycerin (Nitrostat) is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of postcapillary vessels, including large veins, promotes peripheral pooling of blood, decreases venous return to the heart, and reduces left ventricular end-diastolic pressure (preload). Nitroglycerin also produces arteriolar relaxation, thereby reducing peripheral vascular resistance and arterial pressure (afterload), and dilates large epicardial coronary arteries; however, the extent to which this latter effect contributes to the relief of exertional angina is unclear.
Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| MED2005 (0.6 mg) | Experimental | Drug: MED2005, Drug: Nitrostat 0.6Mg Sublingual TabletMED2005 (0.2% GTN) gel to be used topically in Part 1 of the study |
| MED2005 (1.2 mg) | Experimental | Drug: MED2005, Drug: Nitrostat 0.6Mg Sublingual TabletMED2005 (0.4% GTN) gel to be used topically in Part 1 of the study |
| MED2005 (1.8 mg) | Experimental | Drug: MED2005, Drug: Nitrostat 0.6Mg Sublingual TabletMED2005 (0.6% GTN) gel to be used topically in Part 1 of the study |
| Nitrostat (1.8 mg) - Treatment Period 1 | Active comparator | Drug: MED2005, Drug: Nitrostat 0.6Mg Sublingual Tablet3 x 0.6 mg tablets will be required to make up the 1.8 mg dose to be used orally in Part 1 of the study but to be dosed in two treatment periods |
| Nitrostat (1.8 mg) - Treatment Period 2 | Active comparator | Drug: MED2005, Drug: Nitrostat 0.6Mg Sublingual Tablet3 x 0.6 mg tablets will be required to make up the 1.8 mg dose to be used orally in Part 1 of the study but to be dosed in two treatment periods |
| MED2005 (2.4 mg)- Part 1 | Experimental | Drug: MED2005, Drug: Nitrostat 0.6Mg Sublingual TabletMED2005 (0.8% GTN) gel to be used topically in Part 1 of the study |
| Intravenous (I.V.) dose of GTN (0.3 mg) | Active comparator | Drug: Nitro PohlGTN solution for infusion (1 mg/ml) to be used intravenously in Part 2 of the study |
| MED2005 (2.4 mg)- Part 2 | Experimental | Drug: Nitro PohlMED2005 (0.8% GTN) gel to be used topically in Part 2 of the study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male subjects between 18 and 50 years of age, inclusive (at screening).
- A BMI of 18.5-30 kg/m2 (inclusive).
- No clinical significant abnormal serum biochemistry, haematology and urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test may be repeated on admission at the discretion of the Investigator.
- Negative HIV and Hepatitis B and C results.
Key exclusion criteria (17 listed)
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption (Part 1 only).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days (or 5 half-lives (whichever is longer) prior to the first dose of IMP, unless in the opinion of the Investigator and Sponsor's Responsible Physician the medication will not interfere with the study procedures or compose subject safety.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of drug or alcohol abuse within 2 years before the first dose of IMP.
- A clinically significant history of previous allergy/sensitivity to GTN, other nitrates and/or any of the excipients in either the test of reference products.
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 |
|---|---|---|
| MED2005Also: glyceryl trinitrate(Day -1 to Day 1): Subjects will undergo six treatment periods, each separated by at least a two day washout. Each treatment period will be approximately 1 day in duration from the afternoon of Day -1 to the afternoon of Day 1 at 6 hours (h) post-dose. In each of the treatment periods, the subject will receive one of the six administrations over 6 treatment periods (1/period) and will return approximately two days later for the next treatment period. | Drug | MED2005 (0.6 mg), MED2005 (1.2 mg), MED2005 (1.8 mg), MED2005 (2.4 mg)- Part 1, Nitrostat (1.8 mg) - Treatment Period 1, Nitrostat (1.8 mg) - Treatment Period 2 |
| Nitrostat 0.6Mg Sublingual TabletAlso: Nitroglycerin 0.6 mgActive comparator to be used for Part 1 of the study. Nitrostat will be dosed in two treatment periods and 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose. | Drug | MED2005 (0.6 mg), MED2005 (1.2 mg), MED2005 (1.8 mg), MED2005 (2.4 mg)- Part 1, Nitrostat (1.8 mg) - Treatment Period 1, Nitrostat (1.8 mg) - Treatment Period 2 |
| Nitro PohlAlso: Nitroglycerinto be dosed intravenously in Part 2 of the study | Drug | Intravenous (I.V.) dose of GTN (0.3 mg), MED2005 (2.4 mg)- Part 2 |
Primary outcome
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of AUC0-t (Part 1)
Time frame: 22 days
The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of AUC0-inf (Part1)
Time frame: 22 days
The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of Cmax (part1)
Time frame: 22 days
The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN
5 secondary outcomes
The pharmacokinetics of GTN metabolite 1,2-GDN will be evaluated following the administration of MED2005 compared with Nitrostat (Part 1).
Time frame: 22 days
Adverse events (AEs) coded using Medical Dictionary for Regulatory Activities (MedDRA) version 20.0 or higher
Time frame: 46 days
GTN absorption (to quantify the amount of GTN remaining on the glans penis post application)
Time frame: 10 days
GTN absorption (to quantify a figure of 100% GTN being absorbed)
Time frame: 10 days
The pharmacokinetics of GTN metabolite1,3-GDN will be evaluated following the administration of MED2005 compared with Nitrostat (Part 1).
Time frame: 22 days
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 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Samuel Israel, Israel principal investigator
Simbec Research
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 MED2005, Nitrostat 0.6Mg Sublingual Tablet and Nitro Pohl in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 1 site in United Kingdom.
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 14 inclusion and 17 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 5 Jul 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 United Kingdom. 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?
To demonstrate similar or lower bioavailability of GTN when administered as a gel via MED2005 compared to Nitrostat (which will administrated as a sublingual tablet) in terms of AUC0-t (Part 1) (time frame: 22 days). The study lists 3 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 5 Jul 2019.