Healthy VolunteersPhase 1NCT03500224

A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants

A Phase 1 study testing [14C]-TAK-954 in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site in Netherlands.

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 mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify major circulating and excreted metabolites. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: [14C]-TAK-954
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteNetherlands
Study dates: 30 Apr 2018to 1 Jun 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Be a man aged 18 to 55 years, inclusive, at the screening visit.
Have a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50 kilogram (kg) at the screening visit.
Be a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug.
Meet the following birth control requirements:
Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom, from the first dose of study drug until 30 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided that the participant is at least 1 year postbilateral vasectomy procedure before the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year before the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedures should be provided.
Is a male participant who agrees to not donate sperm from trial drug administration on the first day of the first dose until 30 days after the last dose of study drug.

Who cannot join

Has total 14C radioactivity measured by accelerator mass spectrometry in plasma (during screening) exceeding 14C/12C ratio 1.1E-12.
Participated in any study with a radiation dose above 0.1 millibecquerel (MBq) or radiation burden above 0.1 millisievert (mSv) within 1 year before screening.
Was exposed to significant radiation (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months before check-in.
Irregular defecation pattern (less than once per 2 days).
Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer 354 milliliter [mL]/12 ounce [oz], wine 118 mL/4 oz, or distilled spirits 29.5 mL/1 oz).
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
Has a substance abuse disorder.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

PRAHS
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Adult Male Subjects

Read the detailed description

The drug being tested in this study is called TAK-954. This study will assess the mass balance, metabolic profiles and routes of elimination of single intravenous dose of [14C]-TAK-954, and will determine the major circulating and excreted metabolites and single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male participants.

The study will enroll approximately 6 participants. All participants will receive a single dose of [14C]-TAK-954 0.5 mg on Day 1.

This single-center trial will be conducted in Netherlands. The overall time to participate in this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic 15 days after last dose of study drug for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: [14C]-TAK-954
Keywords: Drug therapy

What participants receive

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

[14C]-TAK-954Drug
[14C]-TAK-954 intravenous infusion.

Study groups in NCT03500224
Study group	Role	What they receive
[14C]-TAK-954 0.5 mg	Experimental	[14C]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie [µCi] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1. Receives: Drug: [14C]-TAK-954

What is being measured

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

Cumulative Percentage of Administered Radioactivity Recovered in Urine
Measured: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Administered Radioactivity Recovered in Feces
Measured: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Radioactivity in Urine and Feces Combined
Measured: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cumulative Percentage of Dose Excreted in Urine for TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Dose Excreted in Feces for TAK-954
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Secondary outcomes (4)

Ratio of Total Radioactivity in Whole Blood to Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954
Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
Measured: Baseline up to Day 31
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954
Measured: Baseline up to Day 15

Timeline

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

30 Apr 20181 Jun 2018

First posted18 Apr 2018
Study start30 Apr 2018
Primary completion1 Jun 2018
Study completion1 Jun 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.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03500224
Sponsor's protocol ID: TAK-954-1005
Other IDs: U1111-1202-5762, NL65503.056.18, 2018-001181-42, 2018
Status last verified: May 2019
First submitted: 9 Apr 2018
Last updated: 29 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT03500224
Acronym / sponsor ID: TAK-954-1005
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 30 Apr 2018 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 29 Jul 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

The study will enroll approximately 6 participants. All participants will receive a single dose of [14C]-TAK-954 0.5 mg on Day 1.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C]-TAK-954 0.5 mg	Experimental	Drug: [14C]-TAK-954[14C]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie [µCi] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1.

Who may qualify

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

Key inclusion criteria (6 listed)

Be a man aged 18 to 55 years, inclusive, at the screening visit.
Have a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50 kilogram (kg) at the screening visit.
Be a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug.
Meet the following birth control requirements:

Key exclusion criteria (7 listed)

Has total 14C radioactivity measured by accelerator mass spectrometry in plasma (during screening) exceeding 14C/12C ratio 1.1E-12.
Participated in any study with a radiation dose above 0.1 millibecquerel (MBq) or radiation burden above 0.1 millisievert (mSv) within 1 year before screening.
Was exposed to significant radiation (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months before check-in.
Irregular defecation pattern (less than once per 2 days).
Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer 354 milliliter [mL]/12 ounce [oz], wine 118 mL/4 oz, or distilled spirits 29.5 mL/1 oz).

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
[14C]-TAK-954[14C]-TAK-954 intravenous infusion.	Drug	[14C]-TAK-954 0.5 mg

Primary outcome

Cumulative Percentage of Administered Radioactivity Recovered in Urine
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Administered Radioactivity Recovered in Feces
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Radioactivity in Urine and Feces Combined
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cumulative Percentage of Dose Excreted in Urine for TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Dose Excreted in Feces for TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

4 secondary outcomes

Ratio of Total Radioactivity in Whole Blood to Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 31
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954
Time frame: Baseline up to Day 15

Results and safety

Results posted to the registry on 29 Jul 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
[14C]-TAK-954 0.5 mg	6	4

Primary outcome: Cumulative Percentage of Administered Radioactivity Recovered in Urine

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose. Mean (Standard Deviation). Unit: percentage of radioactive dose

Measure	[14C]-TAK-954 0.5 mg n = 6
0 to 264 hours	55.4 (3.2)
0 to 312 hours	56.8 (3.2)
0 to 336 hours	55.1 (0.4)

Population analysed: The pharmacokinetic (PK) analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.

Primary outcome: Cumulative Percentage of Administered Radioactivity Recovered in Feces

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose. Mean (Standard Deviation). Unit: percentage of radioactive dose

Measure	[14C]-TAK-954 0.5 mg n = 6
0 to 264 hours	28.8 (2.5)
0 to 312 hours	30.3 (2.5)
0 to 336 hours	30.0 (3.5)

Population analysed: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.

Primary outcome: Cumulative Percentage of Radioactivity in Urine and Feces Combined

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose. Mean (Standard Deviation). Unit: percentage of radioactive dose

Measure	[14C]-TAK-954 0.5 mg n = 6
0 to 264 hours	84.1 (5.3)
0 to 312 hours	87.0 (4.6)
0 to 336 hours	85.1 (3.9)

Primary outcome: Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined

Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose. Number. Unit: percentage of dose

Measure	[14C]-TAK-954 0.5 mg n = 6
M1	3.0
M3	13.6
M14	4.3
M4, M5, and M16	5.0
M17	1.6
M7	0.5
M9	0.6
M10	1.0

Population analysed: PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: A treatment-emergent adverse event (TEAE) are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after receiving the study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
[14C]-TAK-954 0.5 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Pain

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

Millennium Pharmaceuticals, Inc.

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 [14C]-TAK-954 in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site in Netherlands.

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 7 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 29 Jul 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 Netherlands. 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 29 Jul 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?

Cumulative Percentage of Administered Radioactivity Recovered in Urine (time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose). The study lists 30 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 NCT03500224.

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 29 Jul 2019.