Healthy VolunteersPhase 1NCT04454918

Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants

A Phase 1 study testing TAK-906 Oral Capsule, [14C]-TAK-906 Intravenous Infusion and [14C]-TAK-906 Oral Solution in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. 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

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-906 Oral Capsule, [14C]-TAK-906 Intravenous Infusion and [14C]-TAK-906 Oral Solution
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: 30 Jul 2020to 30 Sep 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

Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 30.0 kilogram per square meter (kg/m^2) at screening.

Who cannot join

QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is greater than (>) 450 millisecond (msec) or Electrocardiogram (ECG) findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
Estimated creatinine clearance less than (<) 90 milliliter per minute (mL/min) at screening.
Has tattoo(s) or scarring at or near the site of intravenous (IV) 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 last 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]).
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.

Show all 11Show fewer

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.
Unable to refrain from or anticipates the use of:
Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and Milk of Magnesia® (that is, magnesium hydroxide [less than or equal to (<=) 60 mL per day after Day 3 in Period 1 and after Day 8 in Period 2]) may be permitted during the study, only after dosing, if necessary to treat adverse events (AEs). Additional administration of Milk of Magnesia® may be administered on other days at discretion of the Investigator.
Any drugs known to significantly affect the absorption, distribution, metabolism or elimination of TAK-906 within 28 days prior to the first dosing and throughout the study. Appropriate sources (example, Flockhart Table TM) will be consulted to confirm lack of PK/pharmacodynamics interaction with study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Phase 1 Study to Assess Absolute Bioavailability of TAK-906 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Subjects

The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg) (approximately 1 microcurie [μCi]) of [14C]-TAK-906 in Period 1 (ABA), and to determine the mass balance of TAK-906 in urine and feces following a single oral (solution) administration of 50 mg (approximately 100 μCi) of [14C]-TAK-906 in Period 2 (absorption, distribution, metabolism, and elimination [ADME]).

Read the detailed description

The drug being tested in this study is called TAK-906. The study will determine ABA in Period 1, and ADME, and mass balance of TAK-906 after single oral administration in Period 2 in healthy adult male participants. Plasma and urine samples will be collected for PK determination; plasma, whole blood, urine, and feces samples will be collected for total radioactivity (TRA) determination; and plasma, urine, and feces samples will be collected to characterize the metabolite profiles of TAK-906.

The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1 (ABA study period), all participants will receive single unlabeled oral 50 mg dose of TAK-906 as capsule followed by microdose of 100 μg (approximately 1 μCi) [14C]-TAK-906 as intravenous infusion followed by a washout period of at least 7 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 50 mg (approximately 100 μCi) [14C]-TAK-906 as an oral solution.

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-906 Oral Capsule, [14C]-TAK-906 Intravenous Infusion, [14C]-TAK-906 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-906 Oral CapsuleDrug
TAK-906 capsule.
[14C]-TAK-906 Intravenous InfusionDrug
[14C]-TAK-906 intravenous infusion.
[14C]-TAK-906 Oral SolutionDrug
[14C]-TAK-906 oral solution.

Study groups in NCT04454918
Study group	Role	What they receive
TAK-906 50 mg + [14C]-TAK-906 100 mcg + [14C]-TAK-906 50 mg	Experimental	TAK-906 50 mg, capsule, orally, once on Day 1, followed by [14C]-TAK-906 100 micrograms (μg) [approximately 1 microcurie (μCi)], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2. Receives: Drug: TAK-906 Oral Capsule; Drug: [14C]-TAK-906 Intravenous Infusion; Drug: [14C]-TAK-906 Oral Solution

What is being measured

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

Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906
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 for plasma TAK-906, calculated as geometric least squares mean ratio: [Actual Dose (IV) x AUC∞ (oral)] / [Actual Dose (oral) x AUC∞ (IV)] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2

Secondary outcomes (36)

Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: Ceoi: Plasma Total Radioactivity Concentration at the End of Infusion for [14C]-TAK-906
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 Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906
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 Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: CL: Total Clearance for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: Vss: Volume of Distribution During the Terminal Disposition Phase for [14C]-TAK-906
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 [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for [14C]-TAK-906
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 Phase Half-life for [14C]-TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 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 for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUCt: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Time of the Last Common Time Point t for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Whole Blood Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Period 2: AUC∞: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2

Timeline

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

30 Jul 202030 Sep 2020

First posted2 Jul 2020
Study start30 Jul 2020
Primary completion30 Sep 2020
Study completion30 Sep 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.
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: NCT04454918
Sponsor's protocol ID: TAK-906-1007
Other IDs: U1111-1254-4588
Status last verified: Dec 2021
First submitted: 29 Jun 2020
Last updated: 7 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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 7 Mar 2022. 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-906 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04454918
Acronym / sponsor ID: TAK-906-1007
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 Jul 2020 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 2 Jul 2020 (actual)
Results: Posted 7 Mar 2022

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
TAK-906 50 mg + [14C]-TAK-906 100 mcg + [14C]-TAK-906 50 mg	Experimental	Drug: TAK-906 Oral Capsule, Drug: [14C]-TAK-906 Intravenous Infusion, Drug: [14C]-TAK-906 Oral SolutionTAK-906 50 mg, capsule, orally, once on Day 1, followed by [14C]-TAK-906 100 micrograms (μg) [approximately 1 microcurie (μCi)], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once 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 (2 listed)

Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 30.0 kilogram per square meter (kg/m^2) at screening.

Key exclusion criteria (11 listed)

QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is greater than (>) 450 millisecond (msec) or Electrocardiogram (ECG) findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
Estimated creatinine clearance less than (<) 90 milliliter per minute (mL/min) at screening.
Has tattoo(s) or scarring at or near the site of intravenous (IV) 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 last 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]).

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-906 Oral CapsuleTAK-906 capsule.	Drug	TAK-906 50 mg + [14C]-TAK-906 100 mcg + [14C]-TAK-906 50 mg
[14C]-TAK-906 Intravenous Infusion[14C]-TAK-906 intravenous infusion.	Drug	TAK-906 50 mg + [14C]-TAK-906 100 mcg + [14C]-TAK-906 50 mg
[14C]-TAK-906 Oral Solution[14C]-TAK-906 oral solution.	Drug	TAK-906 50 mg + [14C]-TAK-906 100 mcg + [14C]-TAK-906 50 mg

Primary outcome

Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 96 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 for plasma TAK-906, calculated as geometric least squares mean ratio: [Actual Dose (IV) x AUC∞ (oral)] / [Actual Dose (oral) x AUC∞ (IV)] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.
Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2

36 secondary outcomes

Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Period 1: Ceoi: Plasma Total Radioactivity Concentration at the End of Infusion for [14C]-TAK-906
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 Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906
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 Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: CL: Total Clearance for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: Vss: Volume of Distribution During the Terminal Disposition Phase for [14C]-TAK-906
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 [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for [14C]-TAK-906
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 Phase Half-life for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 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 for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUCt: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Time of the Last Common Time Point t for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Whole Blood Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Period 2: AUClast: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Period 2: AUC∞: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2

Results and safety

Results posted to the registry on 7 Mar 2022, 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-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg	6	6

Primary outcome: Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906

Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1. Geometric least squares mean (90% Confidence Interval). Unit: percent absolute bioavailability

Measure	TAK-906 50 mg + [14C]-TAK-906 100 μg n = 6
Value	9.12 (7.49 to 11.10)

Population analysed: Pharmacokinetic (PK) Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion in Period 1 were evaluated for this outcome measure.

Primary outcome: Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906

Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: percentage of dose

Measure	[14C]-TAK-906 50 mg n = 6
Value	2.162 (21.8)

Population analysed: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.

Primary outcome: Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906

Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: percentage of dose

Measure	[14C]-TAK-906 50 mg n = 6
Value	94.44 (1.9)

Primary outcome: Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906

Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2. Geometric mean (Geometric Coefficient of Variation). Unit: percentage of dose

Measure	[14C]-TAK-906 50 mg n = 6
Value	96.65 (1.7)

36 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-906 50 mg + [14C]-TAK-906 100 μg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
[14C]-TAK-906 50 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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

Millennium Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 11 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 7 Mar 2022. 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 7 Mar 2022). 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: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906 (time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1). The study lists 4 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 NCT04454918.

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 7 Mar 2022.