Hepatic ImpairmentPhase 1udenafilNCT00956306
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
A Phase 1 study testing Udenafil in people with Hepatic Impairment, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Udenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Sep 2012
- Phase
- Phase 1
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 20 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males aged 20 to 64 years at screening.
- Non-smokers
- In case of hepatic impaired patients
- In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients
- Subjects within ±20% of the ideal body weight
- 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
- 1.History of portosystemic shunt surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.
- Conditions
- Hepatic Impairment
- Being tested
- Udenafil
- Keywords
- Udenafil,DA-8159,hepatic impairment,healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UdenafilDrug
Also called DA-8159; Zydena
100mg Single Oral Dose of Udenafil
| Study group | Role | What they receive |
|---|---|---|
| Child-Pugh A | Experimental | Not described Receives: Drug: Udenafil |
| Child-Pugh B | Experimental | Not described Receives: Drug: Udenafil |
| Healthy Volunteers | Experimental | Not described Receives: Drug: Udenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC and Cmax), Safety
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startNov 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HYO-SUK LEE, Ph D., Study chair, Seoul National University HospitalYoung-Suk Lim, Ph D., Principal investigator, Asan Medical Center, University of Ulsan Colledge of MedicineHwi Young Kim, Ph D., Principal investigator, SMG-SNU Boramae Medical CenterSook-Hyang Jeong, Ph D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956306
- Sponsor's protocol ID
- DA8159_HI_I
- Acronym
- udenafil
- Status last verified
- Nov 2012
- First submitted
- 10 Aug 2009
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No