Healthy VolunteersPhase 1NCT04234672
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
A Phase 1 study testing TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion and [14C]TAK-831 Oral Suspension in people with Healthy Volunteers, run by Neurocrine Biosciences at 1 site in United States.
Trial summary
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion and [14C]TAK-831 Oral Suspension
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 4 Apr 2020
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Weighs at least 45 kilogram (kg) and body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 32.0 kilogram per square meter (kg/m^2) at screening.
Who cannot join
- Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- Estimated creatinine clearance <80 milliliter per minute (mL/min) at screening.
- Has tattoo(s) or scarring at or near the site of intravenous infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is weighted annual limit recommended by the International Commission on Radiological Protection [ICRP] of 3000 milli roentgen equivalent man [mrem]).
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- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.
Read the detailed description
The drug being tested in this study is called TAK-831 (also known as luvadaxistat). The study will determine ABA in Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-831 after single oral administration in Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.
The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (absorption, distribution, metabolism, and elimination [ADME] study period). In Period 1 (ABA study period), all participants will receive a single unlabelled oral dose of TAK-831 as tablet and a microdose intravenous infusion of 50 μg (approximately 1 μCi) [14C]TAK-831, followed by a washout period of 8 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 500 mg (approximately 100 μCi) [14C]TAK-831 as an oral suspension.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, [14C]TAK-831 Oral Suspension
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-831 Oral TabletDrug
Also called Luvadaxistat
TAK-831 tablet.
[14C]TAK-831 IV InfusionDrug
[14C]TAK-831 IV infusion.
[14C]TAK-831 Oral SuspensionDrug
[14C]TAK-831 oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg | Experimental | TAK-831 500 mg, tablet, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2. Receives: Drug: TAK-831 Oral Tablet; Drug: [14C]TAK-831 IV Infusion; Drug: [14C]TAK-831 Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Percent Absolute Bioavailability (%F) for TAK-831
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
Measured: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose]
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe)
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR])
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe])
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: CLR: Renal Clearance for TAK-831 in Urine
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Secondary outcomes (12)
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
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. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)
Number of Participants With TEAEs Related to Electrocardiogram (ECG)
The ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).
Measured: Up to Day 14
Number of Participants With TEAEs Related to Vital Signs
Vital Signs included body temperature, respiratory rate, blood pressure, and heart rate. Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.
Measured: Up to Day 14
Number of Participants With TEAEs Related to Laboratory Parameters
The laboratory parameters included parameters of hematology, serum checmistry and urinalysis. The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start17 Feb 2020
- Primary completion4 Apr 2020
- Study completion4 Apr 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234672
- Sponsor's protocol ID
- TAK-831-1008
- Other IDs
- U1111-1242-9877
- Status last verified
- Jun 2021
- First submitted
- 16 Jan 2020
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects
- ClinicalTrials.gov ID
- NCT04234672
- Acronym / sponsor ID
- TAK-831-1008
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Posted 28 Apr 2021
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 determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.
Detailed description
The drug being tested in this study is called TAK-831 (also known as luvadaxistat). The study will determine ABA in Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-831 after single oral administration in Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.
The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (absorption, distribution, metabolism, and elimination [ADME] study period). In Period 1 (ABA study period), all participants will receive a single unlabelled oral dose of TAK-831 as tablet and a microdose intravenous infusion of 50 μg (approximately 1 μCi) [14C]TAK-831, followed by a washout period of 8 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 500 mg (approximately 100 μCi) [14C]TAK-831 as an oral suspension.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg | Experimental | Drug: TAK-831 Oral Tablet, Drug: [14C]TAK-831 IV Infusion, Drug: [14C]TAK-831 Oral SuspensionTAK-831 500 mg, tablet, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Weighs at least 45 kilogram (kg) and body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 32.0 kilogram per square meter (kg/m^2) at screening.
Key exclusion criteria (9 listed)
- Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- Estimated creatinine clearance <80 milliliter per minute (mL/min) at screening.
- Has tattoo(s) or scarring at or near the site of intravenous infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
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-831 Oral TabletAlso: LuvadaxistatTAK-831 tablet. | Drug | TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg |
| [14C]TAK-831 IV Infusion[14C]TAK-831 IV infusion. | Drug | TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg |
| [14C]TAK-831 Oral Suspension[14C]TAK-831 oral suspension. | Drug | TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg |
Primary outcome
Period 1: Percent Absolute Bioavailability (%F) for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose]
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe)
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR])
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe])
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Period 2: CLR: Renal Clearance for TAK-831 in Urine
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
12 secondary outcomes
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)
Number of Participants With TEAEs Related to Electrocardiogram (ECG)
Time frame: Up to Day 14
Number of Participants With TEAEs Related to Vital Signs
Time frame: Up to Day 14
Number of Participants With TEAEs Related to Laboratory Parameters
Time frame: Up to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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 Oral Tablet, [14C]TAK-831 IV Infusion and [14C]TAK-831 Oral Suspension 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 9 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 30 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 28 Apr 2021). 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?
Period 1: Percent Absolute Bioavailability (%F) for TAK-831 (time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2021.