Erectile DysfunctionPhase 1NCT00489450
Phase I Study to Investigate the Alcohol Interaction of SK3530
A Phase 1 study testing SK3530 in people with Erectile Dysfunction, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- SK3530
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2007to May 2007
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 20 to 50
- body weight of IBM ± 20%
Who cannot join
- cardiovascular disease
- color-blindness or weakness
- no availability to intake 0.5 g/Kg alcohol
- abnormal supine blood preesure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.
Read the detailed description
This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.
- Conditions
- Erectile Dysfunction
- Being tested
- SK3530
- Keywords
- SK3530, alcohol, pharmacokinetics, safety
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK3530Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters - AUC, Cmax
Measured: 24hr after administration
Secondary outcomes (1)
Safety (Vital signs, Adverse events)
Measured: until post-study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startMar 2007
- Study completionMay 2007
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- In-Jin Jang, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489450
- Sponsor's protocol ID
- SK3530_AI_2006
- Status last verified
- Mar 2007
- First submitted
- 20 Jun 2007
- Last updated
- 21 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes