Healthy Male VolunteersPhase 1NCT01342055
Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
A Phase 1 study testing Apetrol ES in people with Healthy Male Volunteers, run by LG Life Sciences at 1 site in South Korea.
Trial summary
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Apetrol ES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Aug 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a healty male between 20 and 55 years old
- Has BMI result between 19 and 26 kg/m2 at screening
- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Agrees to use an adequate means of contraception during clinical trials
Who cannot join
- Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
- Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
- Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.
- Conditions
- Healthy Male Volunteers
- Being tested
- Apetrol ES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apetrol ESDrug
sequences of administered drugs
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg | Experimental | Not described Receives: Drug: Apetrol ES |
| Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg | Experimental | Not described Receives: Drug: Apetrol ES |
| Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg | Experimental | Not described Receives: Drug: Apetrol ES |
| Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg | Experimental | Not described Receives: Drug: Apetrol ES |
| Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg | Experimental | Not described Receives: Drug: Apetrol ES |
| Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg | Experimental | Not described Receives: Drug: Apetrol ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUClast
Measured: Day 34
Secondary outcomes (1)
AUCinf, Tmax, t1/2(beta)
Measured: Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male VolunteersStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342055
- Sponsor's protocol ID
- LG-ESCL002
- Status last verified
- Oct 2012
- First submitted
- 25 Apr 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim YH, Choi HY, Jin S, Noh YH, Kim MJ, Park HJ, Lim HS, Bang K, Lee SH, Bae KS. Tolerability and pharmacokinetics of two formulations of megestrol acetate under fed conditions in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):439-47. doi: 10.1016/j.clinthera.2014.09.022. Epub 2014 Oct 23.
PubMed 25450470
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01342055
- Acronym / sponsor ID
- LG-ESCL002
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Apr 2011 (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.
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg | Experimental | Drug: Apetrol ES |
| Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg | Experimental | Drug: Apetrol ES |
| Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg | Experimental | Drug: Apetrol ES |
| Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg | Experimental | Drug: Apetrol ES |
| Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg | Experimental | Drug: Apetrol ES |
| Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg | Experimental | Drug: Apetrol ES |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is a healty male between 20 and 55 years old
- Has BMI result between 19 and 26 kg/m2 at screening
- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Agrees to use an adequate means of contraception during clinical trials
Key exclusion criteria (3 listed)
- Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
- Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
- Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history
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 |
|---|---|---|
| Apetrol ESsequences of administered drugs | Drug | Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg, Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg, Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg, Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg, Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg, Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg |
Primary outcome
Cmax, AUClast
Time frame: Day 34
1 secondary outcome
AUCinf, Tmax, t1/2(beta)
Time frame: Day 34
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 10 Oct 2012.
- Derived from this study: PubMed 25450470Kim YH, Choi HY, Jin S, Noh YH, Kim MJ, Park HJ, Lim HS, Bang K, Lee SH, Bae KS. Tolerability and pharmacokinetics of two formulations of megestrol acetate under fed conditions in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):439-47. doi: 10.1016/j.clinthera.2014.09.022. Epub 2014 Oct 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Apetrol ES in people with Healthy Male Volunteers, run by LG Life Sciences 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 4 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 10 Oct 2012. 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?
Cmax, AUClast (time frame: Day 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01342055, which also lists 1 linked publication.
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 10 Oct 2012.