Erectile DysfunctionPhase 1NCT01967264
Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults
A Phase 1 study testing Udenafil in people with Erectile Dysfunction and Phosphodiesterase 5 Inhibitor, run by Takeda at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Phosphodiesterase 5 Inhibitor
- What is being tested?
- Udenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2013to Aug 2013
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign a letter of informed consent prior to performing any procedure.
- Male
- Clinically healthy
- Age between 18 and 55 years old.
- Body Mass Index (BMI) between 18.5 and 24.9.
- Capability and disposition to attend clinical intervention period
Who cannot join
- Current use of any allopathic, over the counter (OTC) (e.g. nutritional supplements) or alternative (e.g. herbal) medication within two weeks prior to trial initiation.
- History of psychiatric diseases.
- History of drug abuse (alcohol, tobacco or any other).
- Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).
- Laboratory tests with clinically significant alterations.
- Intestinal disorders that may modify absorption.
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- History of allergy to the drug or related drugs.
- Blood donation within 45 days prior to study initiation.
- Participation in a clinical trial within 2 months prior to study initiation.
- History of orthostatic alterations or presyncope.
- Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals.
- Inability to communicate or social vulnerability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety Profile and Pharmacokinetic Parameters of Udenafil 150 mg in Healthy Mexican Subjects.
The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.
Read the detailed description
The drug being tested in this study is called Udenafil. Udenafil is being tested to determine a safe and well-tolerated dose. This study will look at vital signs, laboratory tests and side effects in people who take Udenafil.
The study will enroll approximately 84 patients. Participants will be randomly assigned (by chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of the four treatment schemes-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- a) Udenafil-Udenafil
- b) Udenafil- Placebo
- c) Placebo-Udenafil
- d) Placebo-Placebo
All participants will be asked to take one tablet on Day 1 and one tablet on Day 3.
This single-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 7 days. Participants will make 3 visits to the clinic, including 5 days confinement to the clinic, and will be contacted by telephone 15 days after last visit to the clinic for a follow-up assessment.
- Being tested
- Udenafil, Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UdenafilDrug
Udenafil tablets
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Udenafil 150 mg + Udenafil 150 mg | Experimental | Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. Receives: Drug: Udenafil |
| Udenafil 150 mg + Placebo | Experimental | Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. Receives: Drug: Udenafil; Drug: Placebo |
| Placebo + Udenafil 150 mg | Experimental | Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. Receives: Drug: Udenafil; Drug: Placebo |
| Placebo + Placebo | Placebo comparator | Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Adverse Events
AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).
Measured: 3 Weeks
Secondary outcomes (5)
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification
AUC(0-last) is a measure of total plasma exposure to the drug from Time 0 to the last measured concentration above the lower limit of quantification (LLOQ).
Measured: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Measured: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Cmax: Maximum Observed Plasma Concentration
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Terminal Phase Elimination Half-life (T1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
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.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967264
- Sponsor's protocol ID
- PK-MX031
- Other IDs
- U1111-1146-1315
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety Profile and Pharmacokinetic Parameters of Udenafil 150 mg in Healthy Mexican Subjects.
- ClinicalTrials.gov ID
- NCT01967264
- Acronym / sponsor ID
- PK-MX031
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Oct 2013 (estimated)
- 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.
The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.
Detailed description
The drug being tested in this study is called Udenafil. Udenafil is being tested to determine a safe and well-tolerated dose. This study will look at vital signs, laboratory tests and side effects in people who take Udenafil.
The study will enroll approximately 84 patients. Participants will be randomly assigned (by chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of the four treatment schemes-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- a) Udenafil-Udenafil
- b) Udenafil- Placebo
- c) Placebo-Udenafil
- d) Placebo-Placebo
All participants will be asked to take one tablet on Day 1 and one tablet on Day 3.
This single-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 7 days. Participants will make 3 visits to the clinic, including 5 days confinement to the clinic, and will be contacted by telephone 15 days after last visit to the clinic for a follow-up assessment.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Udenafil 150 mg + Udenafil 150 mg | Experimental | Drug: UdenafilUdenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
| Udenafil 150 mg + Placebo | Experimental | Drug: Udenafil, Drug: PlaceboUdenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
| Placebo + Udenafil 150 mg | Experimental | Drug: Udenafil, Drug: PlaceboPlacebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
| Placebo + Placebo | Placebo comparator | Drug: PlaceboPlacebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign a letter of informed consent prior to performing any procedure.
- Male
- Clinically healthy
- Age between 18 and 55 years old.
- Body Mass Index (BMI) between 18.5 and 24.9.
Key exclusion criteria (12 listed)
- Current use of any allopathic, over the counter (OTC) (e.g. nutritional supplements) or alternative (e.g. herbal) medication within two weeks prior to trial initiation.
- History of psychiatric diseases.
- History of drug abuse (alcohol, tobacco or any other).
- Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).
- Laboratory tests with clinically significant alterations.
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 |
|---|---|---|
| UdenafilUdenafil tablets | Drug | Placebo + Udenafil 150 mg, Udenafil 150 mg + Placebo, Udenafil 150 mg + Udenafil 150 mg |
| PlaceboPlacebo tablets | Drug | Placebo + Placebo, Placebo + Udenafil 150 mg, Udenafil 150 mg + Placebo |
Primary outcome
Participants with Adverse Events
Time frame: 3 Weeks
AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).
5 secondary outcomes
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification
Time frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity
Time frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Cmax: Maximum Observed Plasma Concentration
Time frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration
Time frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Terminal Phase Elimination Half-life (T1/2)
Time frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
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 22 Oct 2013.
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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.
Medical Director study director
Takeda
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 Udenafil in people with Erectile Dysfunction and Phosphodiesterase 5 Inhibitor, run by Takeda at 1 site in Mexico.
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 6 inclusion and 12 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 22 Oct 2013. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Participants with Adverse Events (time frame: 3 Weeks). 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 22 Oct 2013.