HealthyPhase 1NCT02372097

A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets

A Phase 1 study testing SYR-472 in people with Healthy, run by Takeda at 1 site in Japan.

Completed

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

Trial summary

The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males. Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SYR-472
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteJapan
Study dates: Mar 2015to Apr 2015
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 20 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Participants who understand the outline of the clinical study and are capable of complying with their responsibilities as participants, as judged by the investigator or sub investigator.
Participants who can sign and date the informed consent form before the initiation of the study procedure.
Healthy Japanese adult males.
Participants who are 20 to 35 years of age at the time of informed consent.
Participants who weigh 50.0 kilogram (kg) or more with a body mass index (BMI) of 18.5 to less than 25.0 kilogram per square meter (kg/m^2) in the screening period.

Who cannot join

Participants who were administered any investigational product within 16 weeks (112 days) before the start of the study drug administration in stage 1.
Participants who have received SYR-472 in the past.
Employees of the study site, their family members, those who are in a dependency relationship with employees of the study site involved in the conduct of the study (for example [e.g.], spouse, parents, children, brothers and sisters), and those who might be coerced to consent to participate in the study.
Participants who have poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lung, liver, kidneys, metabolism, gastrointestinal system, urinary system, or endocrinological system, which possibly may affect study participation or study results.
Participants who have a positive urine drug test in the screening period.
Participants who need to use drugs or foods listed in the table of prohibited concomitant drugs and foods.

Show all 17Show fewer

Participants who have a history of hypersensitivity or allergy to drugs (including SYR-472 and its ingredients).
Participants who currently have or recently had (within the past 6 months) gastrointestinal disease that may affect drug absorption (malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [at least once a week] heartburn, surgical intervention [e.g., cholecystectomy]).
Participants with a past history of cancer.
Participants who are positive for any of the following during the screening period: hepatitis B virus surface antigen (HBsAg), antibody against hepatitis C virus (HCV), human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological test for syphilis.
Participants with difficulty having blood collected from a peripheral vein.
Participants who donated 200 milliliter (mL) or more of whole blood within the 4 weeks (28 days) or 400 mL or more of whole blood within the 12 weeks (84 days) before starting the study drug administration in stage 1.
Participants who donated a total of 800 mL or more of whole blood within the 52 weeks (364 days) before starting the study drug administration in stage 1.
Participants who donated blood components within the 2 weeks (14 days) before starting the study drug administration in stage 1.
Participants who show clinically significant abnormalities in electrocardiogram (ECG) during the screening period or on Day 1 (before the study drug administration).
Participants who have laboratory test abnormalities suggestive of a clinically significant primary disease or who have abnormal values in any of the following parameters: alanine aminotransferase (ALT) or aspartate serum transaminase AST exceeding 1.5 times the upper limit of the normal range.
Participants who are unlikely to comply with the study protocol or are ineligible for the study for any other reason, as judged by the investigator or sub investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka

Other trials in Japan

About this study

Official title: A Randomized, Open-label, Crossover Phase 1 Study to Evaluate the Bioequivalence Following a Single Oral Dose Administration of SYR-472 25mg and 50mg Tablets in Healthy Adult Male Subjects

The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.

Read the detailed description

Bioequivalence of 2 SYR-472 25 mg tablets and 1 SYR-472 50 mg tablet administered to healthy adult males will be investigated in a randomized, open-label, crossover study.

Conditions: Healthy
Being tested: SYR-472

What participants receive

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

SYR-472Drug
SYR-472 25mg, 50mg

Study groups in NCT02372097
Study group	Role	What they receive
Group A	Experimental	Participants in group A will be orally administered 2 tablets of SYR-472 25 mg in period 1 and 1 tablet of SYR-472 50 mg tablet in period 2, both in a single dose under fasting conditions in the morning. Receives: Drug: SYR-472
Group B	Experimental	Participants in group B will be orally administered 1 tablet of SYR-472 50 mg in period 1 and 2 tablets of SYR-472 25 mg tablets in period 2, both in a single dose under fasting conditions in the morning. Receives: Drug: SYR-472

What is being measured

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

AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)
Measured: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Cmax: Maximum Observed Plasma Concentration for SYR-472Z
Measured: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period

Secondary outcomes (9)

AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z
Measured: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Tmax: Time to Reach the Cmax for SYR-472Z
Measured: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z
Measured: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z
Measured: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)
Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29).
Measured: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Related to Vital Signs
Measured: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Related to Body Weight
Measured: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Measured: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Measured: Baseline up to 7 days after the last dose of study drug (Day 8) in each period

Timeline

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

Mar 2015Apr 2015

First posted26 Feb 2015 (estimated)
Study startMar 2015
Primary completionApr 2015
Study completionApr 2015

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 HealthyStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02372097
Sponsor's protocol ID: SYR-472-1005
Other IDs: U1111-1167-0746, JapicCTI-152813, JapicCTI-R160849
Status last verified: Dec 2023
First submitted: 20 Feb 2015
Last updated: 22 Dec 2023
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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Crossover Phase 1 Study to Evaluate the Bioequivalence Following a Single Oral Dose Administration of SYR-472 25mg and 50mg Tablets in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT02372097
Acronym / sponsor ID: SYR-472-1005
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Posted 13 May 2016

Clinical summary

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

The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.

Detailed description

Bioequivalence of 2 SYR-472 25 mg tablets and 1 SYR-472 50 mg tablet administered to healthy adult males will be investigated in a randomized, open-label, crossover study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: SYR-472Participants in group A will be orally administered 2 tablets of SYR-472 25 mg in period 1 and 1 tablet of SYR-472 50 mg tablet in period 2, both in a single dose under fasting conditions in the morning.
Group B	Experimental	Drug: SYR-472Participants in group B will be orally administered 1 tablet of SYR-472 50 mg in period 1 and 2 tablets of SYR-472 25 mg tablets in period 2, both in a single dose under fasting conditions in the morning.

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants who understand the outline of the clinical study and are capable of complying with their responsibilities as participants, as judged by the investigator or sub investigator.
Participants who can sign and date the informed consent form before the initiation of the study procedure.
Healthy Japanese adult males.
Participants who are 20 to 35 years of age at the time of informed consent.
Participants who weigh 50.0 kilogram (kg) or more with a body mass index (BMI) of 18.5 to less than 25.0 kilogram per square meter (kg/m^2) in the screening period.

Key exclusion criteria (17 listed)

Participants who were administered any investigational product within 16 weeks (112 days) before the start of the study drug administration in stage 1.
Participants who have received SYR-472 in the past.
Employees of the study site, their family members, those who are in a dependency relationship with employees of the study site involved in the conduct of the study (for example [e.g.], spouse, parents, children, brothers and sisters), and those who might be coerced to consent to participate in the study.
Participants who have poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lung, liver, kidneys, metabolism, gastrointestinal system, urinary system, or endocrinological system, which possibly may affect study participation or study results.
Participants who have a positive urine drug test in the screening period.

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
SYR-472SYR-472 25mg, 50mg	Drug	Group A, Group B

Primary outcome

AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Cmax: Maximum Observed Plasma Concentration for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period

9 secondary outcomes

AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Tmax: Time to Reach the Cmax for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z
Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Related to Vital Signs
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Related to Body Weight
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration
Time frame: Baseline up to 7 days after the last dose of study drug (Day 8) in each period

Results and safety

Results posted to the registry on 13 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SYR-472 25 mg + SYR-472 50 mg	12	12
SYR-472 50 mg + SYR-472 25 mg	12	12

Primary outcome: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)

Time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period. Geometric mean (Standard Deviation). Unit: nanogram hour per milliliter(ng*hr/mL)

Measure	SYR-472 25 mg n = 24	SYR-472 50 mg n = 24
Value	2733 (445.48)	2780 (437.95)

SYR-472 25 mg vs SYR-472 50 mg: Least square (LS) mean difference: -0.0170 (90% CI -0.0344 to 0.0004)

Population analysed: The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.

Primary outcome: Cmax: Maximum Observed Plasma Concentration for SYR-472Z

Measure	SYR-472 25 mg n = 24	SYR-472 50 mg n = 24
Value	196.5 (54.034)	223.6 (67.200)

SYR-472 25 mg vs SYR-472 50 mg: LS mean difference: -0.1292 (90% CI -0.2177 to -0.0406)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYR-472 25 mg	0 of 24 (0%)	0 of 24 (0%)	Not reported
SYR-472 50 mg	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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.

Medical Director 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 SYR-472 in people with Healthy, run by Takeda at 1 site in Japan.

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 5 inclusion and 17 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 Dec 2023. 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 Japan. 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 13 May 2016). 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?

AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z) (time frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period). 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 NCT02372097.

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 Dec 2023.