HealthyPhase 1NCT01001013
Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
A Phase 1 study testing LC15-0444, Pioglitazone in people with Healthy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each alone in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LC15-0444, Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Dec 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 20 and 45 years at screening
- Subjects with Body Mass Index (BMI) between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI(kg/m2) = body weight(kg)/{height(m)}2.
- Subjects with fasting plasma glucose (FPG) level of 70-125 mg/dL (both inclusive) at the time of screening.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Who cannot join
- Subjects with evidence or history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic (mood disorder, obsessive-compulsive disorder etc.), immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric disease.
- Subjects with evidence or history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or surgery (except appendectomy and herniotomy) possibly affecting drug absorption.
- Subjects with history of hypersensitivities including drug allergies (caused by aspirin, antibiotics, etc.), or history of clinically significant hypersensitivities.
- Subjects who meet the following criteria at the time of the screening examination; Serum AST(SGOT) or ALT(SGPT): > 1.5 times upper normal limit Creatinine clearance calculated by Cockcroft-Gault equation
- < 80 mL/min Clinical significant abnormalities on ECG including 12-lead ECG demonstrating QTc >450 msec at screening or any rhythms except for sinus rhythm
- Subjects who show the following vital sign results at sitting position after resting for 3 min; SBP: ≤ 100 mmHg or ≥ 150 mmHg DBP: ≤ 60 mmHg or ≥ 95 mmHg
Show all 13Show fewer
- Subjects with history of drug abuse or a positive urine result in drug screen for drug abuse or cotinine.
- Subjects who have taken any prescribed medicines or herbal medicines within 2 weeks before the first administration of the investigational product, any non-prescribed medicines or vitamin supplements within 1 week before the first administration of the investigational product. (If other conditions are satisfied, subjects may be eligible for the trial by the investigator's judgment.)
- Subjects who have participated in any other clinical trial within 2 months before the first administration of the investigational product.
- Subjects who have donated a unit of blood within 2 months or blood components within 1 month before the first administration of the investigational product.
- Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or unable to abstain from drinking throughout the trial.
- Smokers (except for those who quit smoking for at least 3 months the first administration of the investigational product)
- Subjects who take caffeine-containing or grapefruit-containing products within 3 days before the first administration of the investigational product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each alone in healthy male subjects.
Read the detailed description
This study is a randomized, open-label, three-treatment, three-period, three-sequence and crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics after the multiple administration of LC15-0444 and pioglitazone concomitantly or each alone.
Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks(-21 d ~ -2 d) before drug administration(1 d). Eligible subjects will be randomized to one of three sequence groups.
According to the characteristics of anti-diabetic drugs, it is expected to be administered with other anti-diabetic drugs. Therefore, Drug-Drug Interaction with Pioglitazone should be identified in this trial.
- Conditions
- Healthy
- Being tested
- LC15-0444, Pioglitazone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC15-0444, PioglitazoneDrug
LC15-0444 200 mg (100 mg x 2) qd (12 days once daily) Pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) LC15-0444 200 mg (100 mg x 2) qd + pioglitazone 30 mg (15 mg x 2) qd (12 days once daily)
| Study group | Role | What they receive |
|---|---|---|
| LC15-0444 200 mg | Experimental | LC15-0444 200 mg Receives: Drug: LC15-0444, Pioglitazone |
| Pioglitazone 30 mg | Experimental | Pioglitazone 30 mg Receives: Drug: LC15-0444, Pioglitazone |
| LC15-0444 200 mg + pioglitazone 30 mg | Experimental | LC15-0444 200 mg + pioglitazone 30 mg Receives: Drug: LC15-0444, Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss, Cmax,ss of LC15-0444 and pioglitazone
Measured: During all dosing visits
Secondary outcomes (1)
Tmax,ss, t1/2, CL/F, Aeτ,ss, CLR, Ctrough,ss of LC15-0444 and pioglitazone AUCτ,ss, Cmax,ss, metabolic ratio of LC15-0444, Pioglitazone metabolites AUC,ss, Cmax,ss, metabolic ratio of pioglitazone metabolites
Measured: During all dosing visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionDec 2009
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001013
- Sponsor's protocol ID
- LG-DPCL003
- Status last verified
- Nov 2010
- First submitted
- 21 Oct 2009
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SE, Yi S, Shin KH, Kim TE, Kim MJ, Kim YH, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetic interaction between the dipeptidyl peptidase IV inhibitor LC15-0444 and pioglitazone in healthy volunteers. Int J Clin Pharmacol Ther. 2012 Jan;50(1):17-23. doi: 10.5414/cp201568.
PubMed 22192641
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01001013
- Acronym / sponsor ID
- LG-DPCL003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Oct 2009 (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.
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each alone in healthy male subjects.
Detailed description
This study is a randomized, open-label, three-treatment, three-period, three-sequence and crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics after the multiple administration of LC15-0444 and pioglitazone concomitantly or each alone.
Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks(-21 d ~ -2 d) before drug administration(1 d). Eligible subjects will be randomized to one of three sequence groups.
According to the characteristics of anti-diabetic drugs, it is expected to be administered with other anti-diabetic drugs. Therefore, Drug-Drug Interaction with Pioglitazone should be identified in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LC15-0444 200 mg | Experimental | Drug: LC15-0444, PioglitazoneLC15-0444 200 mg |
| Pioglitazone 30 mg | Experimental | Drug: LC15-0444, PioglitazonePioglitazone 30 mg |
| LC15-0444 200 mg + pioglitazone 30 mg | Experimental | Drug: LC15-0444, PioglitazoneLC15-0444 200 mg + pioglitazone 30 mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 20 and 45 years at screening
- Subjects with Body Mass Index (BMI) between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI(kg/m2) = body weight(kg)/{height(m)}2.
- Subjects with fasting plasma glucose (FPG) level of 70-125 mg/dL (both inclusive) at the time of screening.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Key exclusion criteria (13 listed)
- Subjects with evidence or history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic (mood disorder, obsessive-compulsive disorder etc.), immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric disease.
- Subjects with evidence or history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or surgery (except appendectomy and herniotomy) possibly affecting drug absorption.
- Subjects with history of hypersensitivities including drug allergies (caused by aspirin, antibiotics, etc.), or history of clinically significant hypersensitivities.
- Subjects who meet the following criteria at the time of the screening examination; Serum AST(SGOT) or ALT(SGPT): > 1.5 times upper normal limit Creatinine clearance calculated by Cockcroft-Gault equation
- Subjects who show the following vital sign results at sitting position after resting for 3 min; SBP: ≤ 100 mmHg or ≥ 150 mmHg DBP: ≤ 60 mmHg or ≥ 95 mmHg
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 |
|---|---|---|
| LC15-0444, PioglitazoneLC15-0444 200 mg (100 mg x 2) qd (12 days once daily) Pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) LC15-0444 200 mg (100 mg x 2) qd + pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) | Drug | LC15-0444 200 mg, LC15-0444 200 mg + pioglitazone 30 mg, Pioglitazone 30 mg |
Primary outcome
AUCτ,ss, Cmax,ss of LC15-0444 and pioglitazone
Time frame: During all dosing visits
1 secondary outcome
Tmax,ss, t1/2, CL/F, Aeτ,ss, CLR, Ctrough,ss of LC15-0444 and pioglitazone AUCτ,ss, Cmax,ss, metabolic ratio of LC15-0444, Pioglitazone metabolites AUC,ss, Cmax,ss, metabolic ratio of pioglitazone metabolites
Time frame: During all dosing visits
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 2 Dec 2010.
- Derived from this study: PubMed 22192641Kim SE, Yi S, Shin KH, Kim TE, Kim MJ, Kim YH, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetic interaction between the dipeptidyl peptidase IV inhibitor LC15-0444 and pioglitazone in healthy volunteers. Int J Clin Pharmacol Ther. 2012 Jan;50(1):17-23. doi: 10.5414/cp201568.
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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.
Kyung-Sang Yu, MD, PhD principal investigator
Seoul National University Hospital
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 LC15-0444, Pioglitazone in people with Healthy, 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 13 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 2 Dec 2010. 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?
AUCτ,ss, Cmax,ss of LC15-0444 and pioglitazone (time frame: During all dosing visits). 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 NCT01001013, 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 2 Dec 2010.