HealthyPhase 1ApetrolNCT02446353
Pharmacokinetics and Safety Study of Apetrol ES
A Phase 1 study testing Apetrol ES / Megace in people with Healthy, run by LG Life Sciences.
Trial summary
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® 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
- What is being tested?
- Apetrol ES / Megace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2010
- 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.
- In a ± 20% than ideal body weight. [ideal body weight(kg) = height(cm)-100) x 0.9 (Broca's rule)
- Subjects who are considered to be suitable in conducting the clinical trial in serum test, hematology test, hemato-chemical test, urine test and 12-ECG result.
- 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
- Subject who has voluntarily decided to participate in this clinical trial and consented in writing.
Who cannot join
- Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history.
- Subjects who have present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system; hematologic and oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc. that may affect ADME of investigational medicinal products.
- In the vital signs measured in sitting position at the screening visit, subjects who have hypertension desease(a systolic blood pressure of ≥ 150 mmHg or a diastolic blood pressure of ≥ 100 mmHg).
- Diabetic patients or the patients who are abnormal of impaired glucose tolerance.
- The patients who have a history of Arterial Embolism.
- The patients who have a history of adrenal insufficiency like hypotension or nausea or vertigo or asthenia or etc.
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- Subjects who have a history of drug abuse or shown positive reaction to drugs that may be abused from a urine drug screening
- Subjects who took any specialized drug or an herbal medication within 2 weeks before the date of first administration or took any over the counter (OTC) drug within 1 week (however, they may be included as subjects if appropriate depending on the investigator's discretion)
- Subjects who had whole blood donation within 2 months or component blood donation within 1 month before the clinical trial.
- Subjects who have abnormal diets that may affect ADME of investigational medicinal products.
- Subjects who have been drinking extremely alcohol and caffeine (more than caffeine 5 cups/day, soju 3 cups/day, beer 3 cups/day, liquors 2 cups/day, 10 cigarettes/day) or can't refrain from drinking during the clinical trial period.
- Subjects who had administration a barbiturates within 1 month before the date of first drug administration
- Subjects who already participated in other clinical trials within 2 months before this clinical trial.
- Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment
About this study
Official title: A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® Under Fasting and Fed Conditions 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® in Healthy Male Volunteers.
Read the detailed description
[Part 1] fasting [Part 2] fed
- Conditions
- Healthy
- Being tested
- Apetrol ES / Megace
- Keywords
- Male Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apetrol ES / MegaceDrug
Also called Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL
Sequences of administered drugs
| Study group | Role | What they receive |
|---|---|---|
| Megace : fed | Experimental | Megace / Apetrol ES : comparator / test, fed Receives: Drug: Apetrol ES / Megace |
| Apetrol ES : fed | Experimental | Apetrol ES / Megace : test / comparator, fed, cross-over Receives: Drug: Apetrol ES / Megace |
| Megace : fasting | Experimental | Megace / Apetrol ES : comparator / test, fasting Receives: Drug: Apetrol ES / Megace |
| Apetrol ES : fasting | Experimental | Apetrol ES / Megace : test / comparator, fasting, cross-over Receives: Drug: Apetrol ES / Megace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
16 times(fasting), 15 times(fed)
Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
AUClast
16 times(fasting), 15 times(fed)
Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Secondary outcomes (3)
AUCinf, %AUCextra
16 times(fasting), 15 times(fed)
Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Tmax
16 times(fasting), 15 times(fed)
Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
t1/2
16 times(fasting), 15 times(fed)
Measured: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionOct 2010
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 HealthyStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Kyungsoo Park, Ph D, MD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446353
- Sponsor's protocol ID
- LG-ESCL001
- Acronym
- Apetrol
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chae DW, Son H, Guk J, Park C, Park K. Pharmacokinetics of a nanocrystal-containing megestrol acetate formulation: a single-dose, randomized, open-label, 2-part, 2-period crossover study in healthy Korean subjects. Int J Clin Pharmacol Ther. 2016 Sep;54(9):698-704. doi: 10.5414/CP202574.
PubMed 27191767
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02446353
- Acronym / sponsor ID
- Apetrol / LG-ESCL001
- Conditions
- Healthy
- Keywords
- Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 May 2015 (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® in Healthy Male Volunteers.
Detailed description
[Part 1] fasting [Part 2] fed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Megace : fed | Experimental | Drug: Apetrol ES / MegaceMegace / Apetrol ES : comparator / test, fed |
| Apetrol ES : fed | Experimental | Drug: Apetrol ES / MegaceApetrol ES / Megace : test / comparator, fed, cross-over |
| Megace : fasting | Experimental | Drug: Apetrol ES / MegaceMegace / Apetrol ES : comparator / test, fasting |
| Apetrol ES : fasting | Experimental | Drug: Apetrol ES / MegaceApetrol ES / Megace : test / comparator, fasting, cross-over |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is a healty male between 20 and 55 years old.
- In a ± 20% than ideal body weight. [ideal body weight(kg) = height(cm)-100) x 0.9 (Broca's rule)
- Subjects who are considered to be suitable in conducting the clinical trial in serum test, hematology test, hemato-chemical test, urine test and 12-ECG result.
- 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 (14 listed)
- Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history.
- Subjects who have present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system; hematologic and oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc. that may affect ADME of investigational medicinal products.
- In the vital signs measured in sitting position at the screening visit, subjects who have hypertension desease(a systolic blood pressure of ≥ 150 mmHg or a diastolic blood pressure of ≥ 100 mmHg).
- Diabetic patients or the patients who are abnormal of impaired glucose tolerance.
- The patients who have a history of Arterial Embolism.
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 ES / MegaceAlso: Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mLSequences of administered drugs | Drug | Apetrol ES : fasting, Apetrol ES : fed, Megace : fasting, Megace : fed |
Primary outcome
Cmax
Time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
AUClast
Time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
3 secondary outcomes
AUCinf, %AUCextra
Time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Tmax
Time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
t1/2
Time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
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 18 May 2015.
- Derived from this study: PubMed 27191767Chae DW, Son H, Guk J, Park C, Park K. Pharmacokinetics of a nanocrystal-containing megestrol acetate formulation: a single-dose, randomized, open-label, 2-part, 2-period crossover study in healthy Korean subjects. Int J Clin Pharmacol Ther. 2016 Sep;54(9):698-704. doi: 10.5414/CP202574.
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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.
Kyungsoo Park, Ph D, MD principal investigator
Yonsei University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apetrol ES / Megace in people with Healthy, run by LG Life Sciences.
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 14 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h). The study lists 2 primary outcomes in all. 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 NCT02446353, 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 18 May 2015.