Renal InsufficiencyPhase 1SK3530_RI_INCT01232010
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
A Phase 1 study testing Mirodenafil in people with Renal Insufficiency and Kidney Diseases, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Kidney Diseases, Urologic Diseases
- What is being tested?
- Mirodenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Dec 2011
- 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 19 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males aged 19 to 64 years at screening.
- Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Who cannot join
- Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
- Subjects with hypotension or hypertension.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.
- Conditions
- Renal Insufficiency, Kidney Diseases, Urologic Diseases
- Being tested
- Mirodenafil
- Keywords
- SK-3530, renal impairment, healthy volunteers
- Medical subject headings
- Renal Insufficiency, Kidney Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirodenafilDrug
50mg Single Oral Dose of
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Not described Receives: Drug: Mirodenafil |
| Patients with severe renal impairment | Experimental | Not described Receives: Drug: Mirodenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC and Cmax)
Measured: 2days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Responsible party
- Principal investigator, Kyun-Seop Bae, Asan Medical Center
- Investigators
- Kyun-Seop Bae, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232010
- Sponsor's protocol ID
- 2007-0445
- Acronym
- SK3530_RI_I
- Status last verified
- Jan 2015
- First submitted
- 1 Nov 2010
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
- ClinicalTrials.gov ID
- NCT01232010
- Acronym / sponsor ID
- SK3530_RI_I / 2007-0445
- Conditions
- Renal Insufficiency, Kidney Diseases, Urologic Diseases
- Keywords
- SK-3530, renal impairment, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- First posted
- 2 Nov 2010 (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.
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: Mirodenafil |
| Patients with severe renal impairment | Experimental | Drug: Mirodenafil |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult males aged 19 to 64 years at screening.
- Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Key exclusion criteria (3 listed)
- Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
- Subjects with hypotension or hypertension.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
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 |
|---|---|---|
| Mirodenafil50mg Single Oral Dose of | Drug | Healthy Volunteers, Patients with severe renal impairment |
Primary outcome
Pharmacokinetics (AUC and Cmax)
Time frame: 2days
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 15 Jan 2015.
- Clinical Research Center, Asan Medical CenterLink provided by the sponsor.
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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.
Kyun-Seop Bae, M.D., Ph.D. principal investigator
Asan Medical Center
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 Mirodenafil in people with Renal Insufficiency and Kidney Diseases, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 3 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 15 Jan 2015. 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 South Korea. 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?
Pharmacokinetics (AUC and Cmax) (time frame: 2days). 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 15 Jan 2015.