Healthy VolunteersPhase 1NCT03101293

A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation

A Phase 1 study testing TAK-831 in people with Healthy Volunteers, run by Neurocrine Biosciences 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 determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation 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-831
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 4 Apr 2017to 26 May 2017
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

1. Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

Who cannot join

Has received TAK-831 in a previous clinical study.
Has poor peripheral venous access.
Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of study drug.
Has any dietary restrictions or preferences that may interfere with the conduct of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRA Health Sciences
Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation in Healthy Subjects

Read the detailed description

The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:

TAK-831 400 mg Fasted + TAK-831 400 mg Fed
TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 23 days. Participants will visit the clinic on Day -1 and remained confined until Day 3 of Intervention Period 1 and 2. A washout period of minimum 7 days will be maintained between the doses in each Intervention Period. Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention Period and will be contacted by telephone 14 days after the last dose of study drug (Day 23) for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: TAK-831
Keywords: Drug therapy

What participants receive

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

TAK-831Drug
TAK-831 film-coated tablet.

Study groups in NCT03101293
Study group	Role	What they receive
TAK-831 400 mg Fasted + TAK-831 400 mg Fed	Experimental	TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 2. Receives: Drug: TAK-831
TAK-831 400 mg Fed + TAK-831 400 mg Fasted	Experimental	TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 2. Receives: Drug: TAK-831

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary outcomes (1)

Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)
Measured: Day 1

Timeline

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

4 Apr 201726 May 2017

First posted5 Apr 2017
Study start4 Apr 2017
Primary completion19 May 2017
Study completion26 May 2017

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 Neurocrine BiosciencesThe 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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03101293
Sponsor's protocol ID: TAK-831-1004
Other IDs: U1111-1189-8001
Status last verified: Jun 2021
First submitted: 28 Mar 2017
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation in Healthy Subjects
ClinicalTrials.gov ID: NCT03101293
Acronym / sponsor ID: TAK-831-1004
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Neurocrine BiosciencesIndustry (pharma, biotech, devices)
Collaborators: Takeda
Study start: 4 Apr 2017 (actual)
Primary completion: 19 May 2017 (actual)
Study completion: 26 May 2017 (actual)
First posted: 5 Apr 2017 (actual)
Results: Posted 18 Mar 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

TAK-831 400 mg Fasted + TAK-831 400 mg Fed
TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 23 days. Participants will visit the clinic on Day -1 and remained confined until Day 3 of Intervention Period 1 and 2. A washout period of minimum 7 days will be maintained between the doses in each Intervention Period. Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention Period and will be contacted by telephone 14 days after the last dose of study drug (Day 23) for a follow-up assessment.

Study design

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

Arm	Type	Receives
TAK-831 400 mg Fasted + TAK-831 400 mg Fed	Experimental	Drug: TAK-831TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 2.
TAK-831 400 mg Fed + TAK-831 400 mg Fasted	Experimental	Drug: TAK-831TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 2.

Who may qualify

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

Key inclusion criteria (1 listed)

1. Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

Key exclusion criteria (4 listed)

Has received TAK-831 in a previous clinical study.
Has poor peripheral venous access.
Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of study drug.
Has any dietary restrictions or preferences that may interfere with the conduct of the study.

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-831TAK-831 film-coated tablet.	Drug	TAK-831 400 mg Fasted + TAK-831 400 mg Fed, TAK-831 400 mg Fed + TAK-831 400 mg Fasted

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

1 secondary outcome

Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1

Results and safety

Results posted to the registry on 18 Mar 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
TAK-831 400 mg Fasted + TAK-831 400 mg Fed	7	7
TAK-831 400 mg Fed + TAK-831 400 mg Fasted	8	8

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-831

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

Measure	TAK-831 400 mg Fasted n = 15	TAK-831 400 mg Fed n = 14
Value	650.04 (47.7)	865.48 (53.5)

TAK-831 400 mg Fasted vs TAK-831 400 mg Fed: LS Mean Ratio: 1.343 (90% CI 1.146 to 1.574), p = 0.0058, ANOVA

Population analysed: The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 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-831

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

Measure	TAK-831 400 mg Fasted n = 15	TAK-831 400 mg Fed n = 14
Value	2290.8 (53.1)	2535.6 (58.8)

TAK-831 400 mg Fasted vs TAK-831 400 mg Fed: LS Mean Ratio: 1.121 (90% CI 0.969 to 1.298), p = 0.1763, ANOVA

Population analysed: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831

Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	TAK-831 400 mg Fasted n = 13	TAK-831 400 mg Fed n = 10
Value	2194.8 (53.1)	2465.9 (67.8)

TAK-831 400 mg Fasted vs TAK-831 400 mg Fed: LS Mean Ratio: 1.154 (90% CI 0.929 to 1.433), p = 0.2745, ANOVA

Population analysed: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug (up to Day 23). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-831 400 mg Fasted	0 of 15 (0%)	0 of 15 (0%)	0 of 15
TAK-831 400 mg Fed	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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-831 in people with Healthy Volunteers, run by Neurocrine Biosciences 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 1 inclusion and 4 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 14 Jun 2021. 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 18 Mar 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 TAK-831 (time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose). 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 NCT03101293.

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 14 Jun 2021.