Healthy VolunteersPhase 1NCT02480439

A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants

A Phase 1 study testing TAK-648 Tablet and TAK-648 Oral Solution in people with Healthy Volunteers, run by Takeda at 1 site in United States.

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 of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy 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?: TAK-648 Tablet and TAK-648 Oral Solution
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 siteUnited States
Study dates: Jun 2015to Sep 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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Weighs at least 50 kilogram (kg) (110 pounds [lbs]) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
Has systolic blood pressure greater than (>) 90 and less than or equal to (<=) 150 millimeter of mercury (mmHg) and diastolic blood pressure >60 and <=90 mm Hg at Screening and at Check-in (Day -1) of Period 1. If out of range, may be repeated once for eligibility determination within a maximum of 5 minutes.
Has a calculated creatinine clearance >60 milliliter per minute (mL/min) at Screening and Check-in (Day -1) of Period 1.
Male participant who is nonsterilized 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 dose.
Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study and for 12 weeks after the last dose.

Who cannot join

Has received any investigational compound within 30 days prior to the first dose of study medication.
Has received TAK-648 in a previous clinical study or as a therapeutic agent.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
Has any significant medical histories or currently uncontrolled clinical conditions, which may render it unsafe for participant to participate in the study, may impact the ability of the participant to participate in the study, or may potentially confound the study results.
Has a history of significant gastrointestinal (GI) disorders manifested with persistent, chronic, or intermittent nausea, vomiting, or diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs.
Has diagnosis of major depression, bipolar disorder, or anxiety disorders, or has received any medication to treat any psychological disorders within 1 year.

Show all 10Show fewer

Has a risk of suicide according to the investigator's clinical judgment per Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or has made a suicide attempt in the past 6 months prior to screening.
Has known hypersensitivity to any component of the formulation of TAK-648, or to a phosphodiesterase type 4 (PDE4) inhibitor (example, roflumilast).
Has taken any excluded medication, supplements, or food products during the time periods listed in the Prohibited Medications table.
Has abnormal Screening or Check-in (Day -1) of Period 1 laboratory values that suggest a clinically significant underlying disease or participant has the following laboratory abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5* upper limit of normal (ULN).

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Austin, Texas

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of a TAK-648 Tablet Compared With a TAK-648 Oral Solution, and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants

Read the detailed description

This study will assess the relative Bioavailability (BA) of TAK-648 tablet compared with that of TAK-648 solution and the effect of food on the BA of the TAK-648 tablet.

The study will enroll approximately 24 healthy participants. Participants will be randomly assigned to one of the three treatment sequences:

TAK-648 tablet in fed state, followed by TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state
TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state, followed by TAK-648 tablet in fed state
TAK-648 oral solution in fasted state, TAK-648 tablet in fed state, TAK-648 tablet in fasted state The dosing in a period and the subsequent period will be separated by a minimum 7-day washout interval. Participants will be asked to take single dose of TAK-648 tablet or oral solution on Day 1 of each period.

This single-center trial will be conducted in the United States. Participants will make 4 visits to the clinic including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: TAK-648 Tablet, TAK-648 Oral Solution
Keywords: Drug Therapy

What participants receive

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

TAK-648 TabletDrug
Tak-648 tablet
TAK-648 Oral SolutionDrug
TAK-648 oral solution

Study groups in NCT02480439
Study group	Role	What they receive
TAK-648 Sequence ABC	Experimental	Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3. Receives: Drug: TAK-648 Tablet; Drug: TAK-648 Oral Solution
TAK-648 Sequence BCA	Experimental	Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3. Receives: Drug: TAK-648 Tablet; Drug: TAK-648 Oral Solution
TAK-648 Sequence CAB	Experimental	Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3. Receives: Drug: TAK-648 Tablet; Drug: TAK-648 Oral Solution

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-648
Measured: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Measured: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Measured: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period

Secondary outcomes (3)

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose
Measured: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute [bpm]).
Measured: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)

Timeline

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

Jun 2015Sep 2015

First posted24 Jun 2015 (estimated)
Study startJun 2015
Primary completionAug 2015
Study completionSep 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 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02480439
Sponsor's protocol ID: TAK-648-1003
Other IDs: U1111-1170-0503
Status last verified: Jul 2016
First submitted: 19 Jun 2015
Last updated: 31 Aug 2016
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 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of a TAK-648 Tablet Compared With a TAK-648 Oral Solution, and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
ClinicalTrials.gov ID: NCT02480439
Acronym / sponsor ID: TAK-648-1003
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Aug 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 24 Jun 2015 (estimated)
Results: Posted 31 Aug 2016

Clinical summary

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

Detailed description

This study will assess the relative Bioavailability (BA) of TAK-648 tablet compared with that of TAK-648 solution and the effect of food on the BA of the TAK-648 tablet.

The study will enroll approximately 24 healthy participants. Participants will be randomly assigned to one of the three treatment sequences:

TAK-648 tablet in fed state, followed by TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state
TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state, followed by TAK-648 tablet in fed state
TAK-648 oral solution in fasted state, TAK-648 tablet in fed state, TAK-648 tablet in fasted state The dosing in a period and the subsequent period will be separated by a minimum 7-day washout interval. Participants will be asked to take single dose of TAK-648 tablet or oral solution on Day 1 of each period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TAK-648 Sequence ABC	Experimental	Drug: TAK-648 Tablet, Drug: TAK-648 Oral SolutionRegimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
TAK-648 Sequence BCA	Experimental	Drug: TAK-648 Tablet, Drug: TAK-648 Oral SolutionRegimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
TAK-648 Sequence CAB	Experimental	Drug: TAK-648 Tablet, Drug: TAK-648 Oral SolutionRegimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.

Who may qualify

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

Key inclusion criteria (6 listed)

Healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Weighs at least 50 kilogram (kg) (110 pounds [lbs]) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
Has systolic blood pressure greater than (>) 90 and less than or equal to (<=) 150 millimeter of mercury (mmHg) and diastolic blood pressure >60 and <=90 mm Hg at Screening and at Check-in (Day -1) of Period 1. If out of range, may be repeated once for eligibility determination within a maximum of 5 minutes.
Has a calculated creatinine clearance >60 milliliter per minute (mL/min) at Screening and Check-in (Day -1) of Period 1.
Male participant who is nonsterilized 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 dose.

Key exclusion criteria (10 listed)

Has received any investigational compound within 30 days prior to the first dose of study medication.
Has received TAK-648 in a previous clinical study or as a therapeutic agent.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
Has any significant medical histories or currently uncontrolled clinical conditions, which may render it unsafe for participant to participate in the study, may impact the ability of the participant to participate in the study, or may potentially confound the study results.
Has a history of significant gastrointestinal (GI) disorders manifested with persistent, chronic, or intermittent nausea, vomiting, or diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs.

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
TAK-648 TabletTak-648 tablet	Drug	TAK-648 Sequence ABC, TAK-648 Sequence BCA, TAK-648 Sequence CAB
TAK-648 Oral SolutionTAK-648 oral solution	Drug	TAK-648 Sequence ABC, TAK-648 Sequence BCA, TAK-648 Sequence CAB

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period

3 secondary outcomes

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose
Time frame: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose
Time frame: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)

Results and safety

Results posted to the registry on 31 Aug 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
TAK-648 Sequence ABC	8	8
TAK-648 Sequence BCA	8	8
TAK-648 Sequence CAB	8	8

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-648

Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period. Mean (Standard Deviation). Unit: mg/mL

Measure	TAK-648 Regimen A n = 23	TAK-648 Regimen B n = 23	TAK-648 Regimen C n = 23
Value	4.504 (1.2363)	4.707 (1.5255)	5.185 (1.9749)

TAK-648 Regimen A vs TAK-648 Regimen B: Point Estimate: 0.9660 (90% CI 0.8747 to 1.0668)
TAK-648 Regimen B vs TAK-648 Regimen C: Point Estimate: 0.9223 (90% CI 0.8352 to 1.0185)

Population analysed: The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.

Primary outcome: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648

Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	TAK-648 Regimen A n = 23	TAK-648 Regimen B n = 23	TAK-648 Regimen C n = 23
Value	34.855 (8.8481)	34.526 (9.2767)	34.916 (10.7221)

TAK-648 Regimen A vs TAK-648 Regimen B: Point Estimate: 0.9998 (90% CI 0.9540 to 1.0477)
TAK-648 Regimen B vs TAK-648 Regimen C: Point Estimate: 1.0149 (90% CI 0.9685 to 1.0636)

Population analysed: The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648

Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	TAK-648 Regimen A n = 23	TAK-648 Regimen B n = 23	TAK-648 Regimen C n = 23
Value	35.241 (8.9283)	34.922 (9.3106)	35.353 (10.7619)

TAK-648 Regimen A vs TAK-648 Regimen B: Point Estimate: 0.9992 (90% CI 0.9541 to 1.0464)
TAK-648 Regimen B vs TAK-648 Regimen C: Point Estimate: 1.0134 (90% CI 0.9676 to 1.0612)

Population analysed: The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study drug to 30 days after last dose (Up to Day 47). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-648 Regimen A	0 of 23 (0%)	4 of 23 (17.4%)	Not reported
TAK-648 Regimen B	0 of 23 (0%)	2 of 23 (8.7%)	Not reported
TAK-648 Regimen C	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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 TAK-648 Tablet and TAK-648 Oral Solution in people with Healthy Volunteers, run by Takeda at 1 site in United States.

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 10 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 31 Aug 2016. 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 United States. 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 31 Aug 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?

Cmax: Maximum Observed Plasma Concentration for TAK-648 (time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period). The study lists 3 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 NCT02480439.

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 31 Aug 2016.