Pharmacokinetics and PharmacodynamicsPhase 1NCT01391663

Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants

A Phase 1 study testing Alogliptin in people with Pharmacokinetics and Pharmacodynamics, run by Takeda at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in healthy Korean subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics and Pharmacodynamics
What is being tested?: Alogliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Korea
Study dates: Jul 2011to Sep 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant is a healthy adult male or female participant of Korean descent.
The participant is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
The participant has a body mass index (BMI) between 18.0 and 26.0 kg/m2, inclusive at Screening.
A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last the dose.
A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.

Who cannot join

The participant has received any investigational compound within 30 days prior to Screening.
The participant has received alogliptin in a previous clinical study or as a therapeutic agent.
The participant is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
The participant has history of uncontrolled, clinically significant manifestations of metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), endocrine, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, skin and subcutaneous tissue disorders, infectious, hepatic, renal, urologic, immunologic, psychiatric or mood disorders (including any past history of suicide attempt), or a history of lactose intolerance, which may impact the ability of the participant to participate or potentially confound the study results.
Participant has a known hypersensitivity to any component of the formulation of alogliptin.
The participant has a positive urine drug result for drugs of abuse or alcohol at Screening or Check-in (Day -1).

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The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
If male, the participant intends to donate sperm during the course of this study or for 12 weeks after the last dose.
Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking alogliptin, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or a known history of human immunodeficiency virus infection at the Screening visit.
Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
The participant has poor peripheral venous access.
Participant has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
Participant has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator.
Participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2x the upper limits of normal.
Participant has a hemoglobin value <12 g/dL at Screening only.
Participant has a systolic blood pressure ≥140 mm Hg or has a diastolic blood pressure ≥90 mm Hg at Screening or Check-in (Day -1).
Participant has a serum creatinine level >1.5 mg/dL at Screening only.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Seoul

Other trials in South Korea

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Dose Study of the Pharmacokinetics and Pharmacodynamics of Alogliptin 12.5 mg, 25 mg and 50 mg in Healthy Korean Subjects

Read the detailed description

Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development Center, Inc. as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying and inhibiting glucagon secretion.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. As development of alogliptin expands to other countries, additional studies are needed to bridge between the data previously acquired.

The main objective of this study is to assess the pharmacokinetics and pharmacodynamics of alogliptin in healthy Korean participants.

Conditions: Pharmacokinetics and Pharmacodynamics
Being tested: Alogliptin
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlogliptinDrug
Also called SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
AlogliptinDrug
Also called SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
AlogliptinDrug
Also called SYR-322
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.

Study groups in NCT01391663
Study group	Role	What they receive
Alogliptin 12.5 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 25 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 50 mg QD	Experimental	Not described Receives: Drug: Alogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
Measured: Day 1-4, Day 10
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
Measured: Day 1-4, Day 10.
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
Measured: Day 1-4
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.
Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
Measured: Day 1-4, Day 10.
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
Measured: Day 1-4
Oral Clearance (CL/F) Pharmacokinetic Parameter
CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.
Measured: Day 1-4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Sep 2011

First posted12 Jul 2011 (estimated)
Study startJul 2011
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pharmacokinetics and PharmacodynamicsStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01391663
Sponsor's protocol ID: SYR-322_106
Other IDs: U1111-1121-7268
Status last verified: Feb 2013
First submitted: 8 Jul 2011
Last updated: 22 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Dose Study of the Pharmacokinetics and Pharmacodynamics of Alogliptin 12.5 mg, 25 mg and 50 mg in Healthy Korean Subjects
ClinicalTrials.gov ID: NCT01391663
Acronym / sponsor ID: SYR-322_106
Conditions: Pharmacokinetics and Pharmacodynamics
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 12 Jul 2011 (estimated)
Results: Posted 22 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The main objective of this study is to assess the pharmacokinetics and pharmacodynamics of alogliptin in healthy Korean participants.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Alogliptin 12.5 mg QD	Experimental	Drug: Alogliptin
Alogliptin 25 mg QD	Experimental	Drug: Alogliptin
Alogliptin 50 mg QD	Experimental	Drug: Alogliptin

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant is a healthy adult male or female participant of Korean descent.
The participant is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
The participant has a body mass index (BMI) between 18.0 and 26.0 kg/m2, inclusive at Screening.

Key exclusion criteria (22 listed)

The participant has received any investigational compound within 30 days prior to Screening.
The participant has received alogliptin in a previous clinical study or as a therapeutic agent.
The participant is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
The participant has history of uncontrolled, clinically significant manifestations of metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), endocrine, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, skin and subcutaneous tissue disorders, infectious, hepatic, renal, urologic, immunologic, psychiatric or mood disorders (including any past history of suicide attempt), or a history of lactose intolerance, which may impact the ability of the participant to participate or potentially confound the study results.
Participant has a known hypersensitivity to any component of the formulation of alogliptin.

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
AlogliptinAlso: SYR-322Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.	Drug	Alogliptin 12.5 mg QD
AlogliptinAlso: SYR-322Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.	Drug	Alogliptin 25 mg QD
AlogliptinAlso: SYR-322Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.	Drug	Alogliptin 50 mg QD

Primary outcome

Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
Time frame: Day 1-4, Day 10
Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Time frame: Day 1-4, Day 10.
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
Time frame: Day 1-4
Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.
Time frame: Day 1-4, Day 10.
Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
Time frame: Day 1-4
Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
Oral Clearance (CL/F) Pharmacokinetic Parameter
Time frame: Day 1-4
CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.

Results and safety

Results posted to the registry on 22 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alogliptin 12.5 mg QD	12	12
Alogliptin 25 mg QD	12	12
Alogliptin 50 mg QD	12	11
Placebo	12	12

Primary outcome: Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter

Time frame: Day 1-4, Day 10. Mean (Standard Deviation). Unit: ng/mL

Measure	Alogliptin 12.5 mg QD n = 12	Alogliptin 25 mg QD n = 12	Alogliptin 50 mg QD n = 12	Placebo n = 12
Day 1 (n=12; n=12; n=12; n=12)	55.28 (10.700)	114.08 (36.611)	246.00 (89.699)	NA (NA)
Day 10 (n=12; n=12; n=11; n=12)	75.38 (14.708)	154.83 (34.842)	335.36 (61.983)	NA (NA)

Population analysed: Healthy Korean Participants

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

Time frame: Day 1-4, Day 10.. Median (Full Range). Unit: hr

Measure	Alogliptin 12.5 mg QD n = 12	Alogliptin 25 mg QD n = 12	Alogliptin 50 mg QD n = 12	Placebo n = 12
Day 1 (n=12; n=12; n=12; n=12)	1.49 (1.00 to 6.00)	1.01 (0.52 to 3.033)	3.00 (0.52 to 6.08)	NA (NA to NA)
Day 10 (n=12; n=12; n=11; n=12)	1.02 (0.97 to 6.00)	2.00 (0.98 to 6.00)	1.02 (0.48 to 4.00)	NA (NA to NA)

Population analysed: Healthy Korean Participants

Primary outcome: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter

Time frame: Day 1-4. Mean (Standard Deviation). Unit: ng·hr/mL

Measure	Alogliptin 12.5 mg QD n = 12	Alogliptin 25 mg QD n = 12	Alogliptin 50 mg QD n = 12	Placebo n = 12
Value	895.28 (78.639)	1674.88 (308.115)	3306.68 (530.295)	NA (NA)

Population analysed: Healthy Korean Participants

Primary outcome: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.

Time frame: Day 1-4, Day 10.. Mean (Standard Deviation). Unit: ng·hr/mL

Measure	Alogliptin 12.5 mg QD n = 12	Alogliptin 25 mg QD n = 12	Alogliptin 50 mg QD n = 12	Placebo n = 12
Day 1 (n=12; n=12; n=12; n=12)	601.65 (77.520)	1174.76 (184.062)	2488.48 (408.016)	NA (NA)
Day 10 (n=12; n=12; n=11; n=12)	842.17 (84.110)	1625.58 (397.301)	3389.21 (406.082)	NA (NA)

Population analysed: Healthy Korean Participants

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin 12.5 mg QD	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Alogliptin 25 mg QD	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Alogliptin 50 mg QD	0 of 12 (0%)	4 of 12 (33.3%)	Not reported
Placebo	0 of 12 (0%)	3 of 12 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Director Clinical Science study director

Takeda

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 Alogliptin in people with Pharmacokinetics and Pharmacodynamics, run by Takeda 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 7 inclusion and 22 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 22 Mar 2013. 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?

Yes. Results are posted in the registry (first posted 22 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Maximum Observed Plasma Concentration Pharmacokinetic Parameter (time frame: Day 1-4, Day 10). The study lists 6 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 NCT01391663.

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 22 Mar 2013.