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Healthy ParticipantsPhase 1NCT04745767

A Study of Different Forms of TAK-994 in Healthy Adults

A Phase 1 study testing TAK-994 in people with Healthy Participants, run by Takeda at 2 sites 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

It is hoped that TAK-994 will eventually help people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day, including falling asleep suddenly. Before then, the sponsor needs to understand how the body processes TAK-994. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
TAK-994
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesUnited States
Study dates
16 Feb 2021to 5 Apr 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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 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.

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.
  • Current or past history of epilepsy, seizure, or 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).
  • 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.
Show all 10Show fewer
  • Is lactose intolerant or unable/unwilling to eat the high-fat/high-calorie breakfast.
  • 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 (whichever is longer) 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 Period 1 of the current study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Celerion Lincoln, NE site

    Lincoln, Nebraska, 68502

  • Celerion Tempe, AZ site

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of Different TAK-994 Formulations and the Effect of Food on These Formulations in Healthy Adult Subjects

It is hoped that TAK-994 will eventually help people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day, including falling asleep suddenly. Before then, the sponsor needs to understand how the body processes TAK-994.

The main aims of the study are to learn how the body processes 4 different new forms of TAK-994, when taken with food and without food, compared to a standard form of TAK-994.

Read more

At the first visit, the study doctor will check who can take part. Then the participants will be picked for 1 of 3 groups by chance. These groups of participants will take different new forms of TAK-994 and the standard form. They will take these with and without food. This will happen again 3 or 4 times but will take TAK-994 in a different order each time. After each treatment with TAK-994, the study doctors will check the amount of TAK-994 in the blood of the participants, over time. The study doctors will also check if the participants have any side effects from TAK-994.

Participants will wait 5 or more days between each dose to allow time for TAK-994 to completely leave their bodies. Participants will stay in the clinic during their treatment with TAK-994. They will stay in the clinic for 15 days or longer. Participants who have 4 treatments with TAK-994 will stay in the clinic for 20 days or longer.

Then, the clinic will telephone the participants 12 days after their final treatment of TAK-994 to check if they have any health problems.

Read the detailed description

The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy participants. This study will look at the relative BA of different TAK-994 test formulations relative to the currently used formulation (T1) and the effect of food on the test formulations in healthy participants.

The study will enroll approximately 54 participants. The study consists of three parallel groups (Group 1, Group 2, and Group 3). In each group, one test TAK-994 formulation (T2 formulations in Group 1; T3 formulations in Group 2; and T4 and T5 formulations in Group 3) will be evaluated under fed and fasting condition compared to reference T1 formulation under fasting conditions in a cross-over design. Participants will be randomly assigned into 6 sequences within each group.

This multi-center trial will be conducted in United States. The overall time to participate in this study is approximately 57 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.

Being tested
TAK-994
Keywords
Drug Therapy

What participants receive

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

  • TAK-994Drug

    T2 formulation.

  • TAK-994Drug

    T1 formulation.

  • TAK-994Drug

    T3 formulation.

  • TAK-994Drug

    T4 formulation.

  • TAK-994Drug

    T5 formulation.

Study groups in NCT04745767
Study groupRoleWhat they receive
Group 1: A1(T1), B(T2), C(T2 Fed)ExperimentalParticipants will be randomly placed into 6 sequences within Group 1. All participants in Group 1 will receive TAK-994 as Treatment A1 (T1 Formulation) and Treatment B (T2 Formulation) under fasted conditions and Treatment C (T2 Formulation) under fed conditions at different times within three periods.
Receives: Drug: TAK-994
Group 2: A2(T1), D(T3), E(T3 Fed)ExperimentalParticipants will be randomly placed into 6 sequences within Group 2. All participants in Group 2 will receive TAK-994 as Treatment A2 (T1 Formulation) and Treatment D (T3 Formulation) under fasted conditions and Treatment E (T3 Formulation) under fed conditions at different times within three periods.
Receives: Drug: TAK-994
Group 3: A3(T1), F(T4), G(T4 Fed), H(T5)ExperimentalParticipants will be randomly placed into 6 sequences within Group 3. Participants in Group 3 will receive TAK-994 as Treatment A3 (T1 Formulation), Treatment F (T4 Formulation), and Treatment F (T5 Formulation) under fasted conditions and Treatment G (T4 Formulation) under fed conditions at different times within 4 periods.
Receives: Drug: TAK-994

What is being measured

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

  1. Cmax : Maximum Observed Plasma Concentration for TAK-994

    Measured: Day 1: Pre-dose and at multiple time points (up to 72 hours) post-dose

  2. 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 72 hours) post-dose

  3. 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 72 hours) post-dose

Secondary outcomes (1)

  1. Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)

    Measured: Day 1 up to 14 days after last dose of study drug (up to Day 33)

Timeline

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

  1. First posted9 Feb 2021
  2. Study start16 Feb 2021
  3. Primary completion25 Mar 2021
  4. Study completion5 Apr 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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745767
Sponsor's protocol ID
TAK-994-1006
Status last verified
Apr 2021
First submitted
5 Feb 2021
Last updated
22 Apr 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 in people with Healthy Participants, run by Takeda at 2 sites 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 2 inclusion and 10 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 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Cmax : Maximum Observed Plasma Concentration for TAK-994 (time frame: Day 1: Pre-dose and at multiple time points (up to 72 hours) post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04745767.

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 22 Apr 2021.

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