Healthy VolunteersPhase 1NCT03501277

A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants

A Phase 1 study testing Alogliptin, Pioglitazone and SYR-322-4833 BL in people with Healthy Volunteers, run by Takeda at 1 site in Russia.

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 relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Alogliptin, Pioglitazone and SYR-322-4833 BL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteRussia
Study dates: 26 May 2018to 11 Jul 2018
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

Is a healthy male or female.
Has an estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter per minute (mL/min).
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

Who cannot join

Has participated in a clinical study within 3 months prior to Check-in (Day-1).
Has a fasting blood glucose level lower than 3.88 millimole per liter (mmol/L).
Has received alogliptin or pioglitazone in a previous clinical study or as a therapeutic agent within 90 days prior to Check-in (Day-1).
Experienced acute infectious diseases within 4 weeks prior to Screening.
Has a positive urine drug result for super potent substances and drugs of abuse (defined as any illicit drug use) or positive alcohol breath test at Screening or Check-in (Day -1).
Consumes over 10 drinks weekly (1 drink is equivalent to 0.5 liters of beer, 200 milliliter (mL) of dry wine or 50 mL of ardent spirits) or has a history of alcoholism, drug and/or substance abuse.

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Has a non-standard diet (example, vegetarian or vegan) or lifestyle (including night time work, extreme physical activity such as weights lifting), which may interfere with the trial.
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).
Has poor peripheral venous access.
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 of Period 1.
Has consumed caffeine or xanthine-containing food or drinks within 72 hours prior to Check-in (Day -1).
Has dehydration due to vomiting, diarrhea, or any other reason within 24 hours prior to study start.
Has drug intolerance.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways
Yaroslavl, 150047

Other trials in Russia

About this study

Official title: A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects

Read the detailed description

The drug being tested in this study are called Incresync (SYR-322-4833 BL), alogliptin, and pioglitazone. This study will assess the bioequivalence, pharmacokinetics (PK), and safety of alogliptin and pioglitazone administered as individual tablets and as the FDC tablet product in healthy volunteers.

The study will enroll approximately 72 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment sequences to receive one of the following treatments:

Regimen A: SYR-322-4833 BL (25 mg + 15 mg)
Regimen B: Alogliptin 25 mg + pioglitazone 15 mg
Regimen C: SYR-322-4833 BL (25 mg + 30 mg)
Regimen D: Alogliptin 25 mg + pioglitazone 30 mg

All participants will be asked to take single dose of study medication on Day 1 of each intervention period.

This single center trial will be conducted in Russia. The overall time to participate in this study is 66 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after their last dose of drug for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: Alogliptin, Pioglitazone, SYR-322-4833 BL
Keywords: Drug therapy

What participants receive

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

AlogliptinDrug
Alogliptin tablets.
PioglitazoneDrug
Pioglitazone tablets.
SYR-322-4833 BLDrug
Also called Incresync
SYR-322-4833 BL FDC tablets.

Study groups in NCT03501277
Study group	Role	What they receive
Sequence I: ABCD	Experimental	SYR-322-4833 BL (alogliptin 25 [milligram] mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D). Receives: Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL
Sequence II: BCDA	Experimental	Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A). Receives: Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL
Sequence III: CDAB	Experimental	SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B). Receives: Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL
Sequence IV: DABC	Experimental	Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C). Receives: Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Timeline

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

26 May 201811 Jul 2018

First posted18 Apr 2018
Study start26 May 2018
Primary completion11 Jul 2018
Study completion11 Jul 2018

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 Healthy VolunteersStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03501277
Sponsor's protocol ID: Alogliptin-1002
Other IDs: U1111-1196-9223
Status last verified: Jun 2019
First submitted: 9 Apr 2018
Last updated: 8 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects
ClinicalTrials.gov ID: NCT03501277
Acronym / sponsor ID: Alogliptin-1002
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 26 May 2018 (actual)
Primary completion: 11 Jul 2018 (actual)
Study completion: 11 Jul 2018 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 8 Aug 2019

Clinical summary

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

Detailed description

Regimen A: SYR-322-4833 BL (25 mg + 15 mg)
Regimen B: Alogliptin 25 mg + pioglitazone 15 mg
Regimen C: SYR-322-4833 BL (25 mg + 30 mg)
Regimen D: Alogliptin 25 mg + pioglitazone 30 mg

All participants will be asked to take single dose of study medication on Day 1 of each intervention period.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence I: ABCD	Experimental	Drug: Alogliptin, Drug: Pioglitazone, Drug: SYR-322-4833 BLSYR-322-4833 BL (alogliptin 25 [milligram] mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).
Sequence II: BCDA	Experimental	Drug: Alogliptin, Drug: Pioglitazone, Drug: SYR-322-4833 BLAlogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).
Sequence III: CDAB	Experimental	Drug: Alogliptin, Drug: Pioglitazone, Drug: SYR-322-4833 BLSYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).
Sequence IV: DABC	Experimental	Drug: Alogliptin, Drug: Pioglitazone, Drug: SYR-322-4833 BLAlogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).

Who may qualify

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

Key inclusion criteria (3 listed)

Is a healthy male or female.
Has an estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter per minute (mL/min).
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

Key exclusion criteria (13 listed)

Has participated in a clinical study within 3 months prior to Check-in (Day-1).
Has a fasting blood glucose level lower than 3.88 millimole per liter (mmol/L).
Has received alogliptin or pioglitazone in a previous clinical study or as a therapeutic agent within 90 days prior to Check-in (Day-1).
Experienced acute infectious diseases within 4 weeks prior to Screening.
Has a positive urine drug result for super potent substances and drugs of abuse (defined as any illicit drug use) or positive alcohol breath test at Screening or Check-in (Day -1).

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
AlogliptinAlogliptin tablets.	Drug	Sequence I: ABCD, Sequence II: BCDA, Sequence III: CDAB, Sequence IV: DABC
PioglitazonePioglitazone tablets.	Drug	Sequence I: ABCD, Sequence II: BCDA, Sequence III: CDAB, Sequence IV: DABC
SYR-322-4833 BLAlso: IncresyncSYR-322-4833 BL FDC tablets.	Drug	Sequence I: ABCD, Sequence II: BCDA, Sequence III: CDAB, Sequence IV: DABC

Primary outcome

Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Results and safety

Results posted to the registry on 8 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence I: ABCD	18	18
Sequence II: BCDA	18	18
Sequence III: CDAB	18	17
Sequence IV: DABC	18	17

Primary outcome: Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone

Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/ml)

Measure	Regimen A n = 70	Regimen B n = 69	Regimen C n = 68	Regimen D n = 70
Alogliptin	165.3 (42.87)	154.9 (44.71)	162.3 (51.19)	157.4 (44.24)
Pioglitazone	678.3 (267.58)	706.5 (254.12)	1052.1 (478.13)	1141.5 (509.78)

Regimen A vs Regimen B: Least Square Mean (LSM) difference: 1.0706 (90% CI 1.0230 to 1.1204), p = 0.014, ANOVA
Regimen C vs Regimen D: LSM difference: 1.0276 (90% CI 0.9817 to 1.0757), p = 0.326, ANOVA
Regimen A vs Regimen B: LSM diiference: 0.9594 (90% CI 0.8837 to 1.0415), p = 0.405, ANOVA

Population analysed: The pharmacokinetic (PK) analysis set included all participants in the safety set who had sufficient plasma concentration data to facilitate the derivation of at least 1 PK parameter.

Primary outcome: AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone

Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose. Geometric mean (Standard Deviation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Regimen A n = 70	Regimen B n = 69	Regimen C n = 68	Regimen D n = 70
Alogliptin	2197.3 (340.92)	2163.4 (362.83)	2194.7 (379.27)	2195.0 (379.80)
Pioglitazone	5726.0 (1826.18)	5471.9 (1766.76)	10141.6 (3611.38)	9907.6 (3495.57)

Regimen A vs Regimen B: LSM difference: 1.0157 (90% CI 1.0009 to 1.0308), p = 0.081, ANOVA
Regimen C vs Regimen D: LSM difference: 1.0009 (90% CI 0.9862 to 1.0158), p = 0.922, ANOVA
Regimen A vs Regimen B: LSM difference: 1.0486 (90% CI 1.0051 to 1.0939), p = 0.066, ANOVA

Population analysed: The PK analysis set included all participants in the safety set who had sufficient plasma concentration data to facilitate the derivation of at least 1 PK parameter.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A	0 of 70 (0%)	2 of 70 (2.9%)	0 of 70
Regimen B	0 of 69 (0%)	1 of 69 (1.4%)	0 of 69
Regimen C	0 of 68 (0%)	1 of 68 (1.5%)	0 of 68
Regimen D	0 of 70 (0%)	2 of 70 (2.9%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
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 Alogliptin, Pioglitazone and SYR-322-4833 BL in people with Healthy Volunteers, run by Takeda at 1 site in Russia.

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 3 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 8 Aug 2019. 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 Russia. 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 8 Aug 2019). 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 for Alogliptin and Pioglitazone (time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose). 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 NCT03501277.

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 8 Aug 2019.