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Healthy VolunteersPhase 1NCT04833049

Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults

A Phase 1 study testing TAK-994 Oral Tablet, [14C]TAK-994 Intravenous Infusion and [14C]TAK-994 Oral Suspension in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994. 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-994 Oral Tablet, [14C]TAK-994 Intravenous Infusion and [14C]TAK-994 Oral Suspension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
14 Apr 2021to 20 Jun 2021
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 32.0 kilogram per square meter (kg/m^2) at the screening.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
  • Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing and throughout the study, based on participant self-reporting.
  • Agrees to comply with any applicable contraceptive requirements of the protocol.
  • Agree not to donate sperm from the first dosing until 95 days after the last dosing.
  • Agree and able to remain in the clinical research unit (CRU) for the duration of the study.
  • Understands the study procedures in the ICF, and be willing and able to comply with the protocol.
  • Able to swallow oral suspensions.

Who cannot join

  • Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
  • History or presence of gastritis, gastrointestinal tract, hepatic disorder, cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease, or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug.
  • History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the Diagnostic and Statistical Manual of Mental Disorders-V criteria.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
Show all 30Show fewer
  • Current or past history of epilepsy, seizure, convulsion, tremor, or related symptoms.
  • Positive urine drug or alcohol results at screening or check-in.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  • 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 45 beats per minute (bpm) or higher than 100 bpm at screening.
  • Orthostatic vital sign results with a decrease in systolic greater than (>) 20 mmHg or decrease in diastolic >10 mmHg, and increase in pulse of >20 bpm.
  • QT interval corrected for heart rate using Frederica's equation (QTcF) is >450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
  • Liver function tests including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5*upper limit of normal (ULN) at screening or check-in.
  • Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.
  • Tattoo(s) or scarring at or near the site of IV infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator of designee;
  • Infrequent bowel movements (less than approximately once per day) within 30 days prior to dosing.
  • Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of dosing.
  • Lactose intolerance.
  • 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 millirem [mrem]).
  • 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. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After first dosing and throughout the study, ibuprofen (up to 1.2 gram [g] per 24 hours) may be administered at the discretion of the Investigator or designee. Milk of Magnesia (that is, magnesium hydroxide) (less than or equal to [<=] 60 milliliter [mL] per day) may be administered from Day 3 of each study part, at discretion of the Investigator, to ensure defecation.
  • Any drugs known to be significant inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study, including the follow-up period. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of pharmacokinetics (PK)/pharmacodynamics interaction with study drug.
  • Participation in another clinical study treated with the radiolabeled drug within 6 months prior to the first dosing.
  • Participants has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 mL/12 Ounce [oz]], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).
  • Participant consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  • 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.
  • Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Part A of the current study.

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-994 and to Characterize Mass Balance, Pharmacokinetics, Absorption, Metabolism, and Excretion of [14C]TAK-994 in Male Healthy Subjects

The aim of this study is to understand how TAK-994 is processed by the body.

This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.

Read the detailed description

The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing.

The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B.

In Part A, all participants will receive TAK-994 as tablet and [14C]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of [14C]TAK-994 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 67 days, including a 28-day screening period plus approximately 30 days for follow up.

Being tested
TAK-994 Oral Tablet, [14C]TAK-994 Intravenous Infusion, [14C]TAK-994 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-994 Oral TabletDrug

    TAK-994 tablet.

  • [14C]TAK-994 Intravenous InfusionDrug

    [14C]TAK-994 intravenous infusion.

  • [14C]TAK-994 Oral SuspensionDrug

    [14C]TAK-994 oral suspension.

Study groups in NCT04833049
Study groupRoleWhat they receive
TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3ExperimentalTAK-994 Dose 1, tablet, orally, on Day 1, followed by [14C]TAK-994 Dose 2, infusion, intravenously, on Day 1 of Part A, followed by a washout period of at least 8 days, further followed by [14C]TAK-994 Dose 3, suspension, orally, on Day 1 of Part B.
Receives: Drug: TAK-994 Oral Tablet; Drug: [14C]TAK-994 Intravenous Infusion; Drug: [14C]TAK-994 Oral Suspension

What is being measured

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

  1. Part A: Percent Absolute Bioavailability (%F) for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  2. Part B: Percentage of Total Radioactivity (TRA) in Urine (Cum Percent [%] Dose [UR]) Relative to the Administered Radioactive Dose

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  3. Part B: Percentage of TRA in Feces (Cum%Dose[FE]) Relative to the Administered Radioactive Dose

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  4. Part B: Percentage of TRA Recovered in in the Urine and Feces Combined (Combined Cum%Dose) Relative to the Administered Radioactive Dose

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Secondary outcomes (19)

  1. Part A, Ceoi: Plasma Concentration at the end of Infusion for [14C]TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  2. Part A, CL: Total Clearance for [14C]TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  3. Part A, Vss: Volume of Distribution at Steady State After Intravenous Administration for [14C]TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  4. Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 and [14C]TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  5. Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 and [14C]TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  6. Part A, t(1/2z): Terminal Disposition Half-life for TAK-994 and [14C]TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  7. Part A, Cmax: Maximum Observed Plasma Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  8. Part A, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

  9. Part B, Cmax: Maximum Observed Plasma Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  10. Part B, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  11. Part B, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  12. Part B, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  13. Part B, t(1/2z): Terminal Disposition Half-life for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  14. Part B, Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  15. Part B, Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  16. Part B, AUClast: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  17. Part B, AUC∞: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Infinity for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  18. Part B, AUCt: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Time t for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

  19. Part B, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood TRA Concentration for TAK-994

    Measured: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Timeline

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

  1. First posted6 Apr 2021
  2. Study start14 Apr 2021
  3. Primary completion20 Jun 2021
  4. Study completion20 Jun 2021

Resources

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
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04833049
Sponsor's protocol ID
TAK-994-1004
Status last verified
Jun 2021
First submitted
5 Apr 2021
Last updated
29 Jun 2021
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-994 Oral Tablet, [14C]TAK-994 Intravenous Infusion and [14C]TAK-994 Oral Suspension in people with Healthy Volunteers, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part A: Percent Absolute Bioavailability (%F) for TAK-994 (time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose). 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 NCT04833049.

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 Jun 2021.

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