TAK-105 for Healthy Subjects

No longer recruiting at 2 trial locations

Overseen By Takeda Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: All medications

Disqualifiers: Allergies, Pregnancy, COVID-19, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TAK-105, which researchers hope will help with nausea and vomiting in the future. The main goal is to observe the body's reaction to TAK-105 and identify any side effects. Participants will receive either TAK-105 or a placebo (a dummy treatment with no active ingredient) as an injection. Healthy adults who do not smoke and are in good health may be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive TAK-105, aiding researchers in understanding how this new treatment works in people.

Will I have to stop taking my current medications?

Yes, participants must stop taking all medications, including herbal medicines, starting about 7 days before the first dose and throughout the study until the last follow-up visit.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TAK-105 has been tested in healthy adults to assess side effects. Early results suggest that participants can tolerate various doses of the treatment. Although specific safety information for TAK-105 is not yet available, similar compounds like TAK-242 have been tested in rats. These animal studies help researchers understand potential effects on humans. This trial is in an early stage, primarily focused on determining the safety of TAK-105 for people. Currently, the treatment undergoes careful testing to establish the maximum dose that can be administered without causing side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

TAK-105 is unique because it offers a new approach to treatment through its subcutaneous injection delivery, potentially improving patient convenience and compliance. Unlike existing treatments that may require more frequent administration, TAK-105 is designed to be administered less frequently, with some doses given just once or weekly. Researchers are excited about TAK-105 as it targets the condition with a potentially more efficient mechanism, which could lead to faster and more effective outcomes.

What evidence suggests that TAK-105 might be an effective treatment for nausea and vomiting?

Initial findings suggest that TAK-105 might help reduce nausea and vomiting. Similar compounds have worked well in past studies to control these symptoms. Although TAK-105 is still under investigation in this trial, researchers remain hopeful due to its design, which mirrors those successful compounds. Current research focuses on ensuring TAK-105's safety and understanding its mechanism in the body. This background provides some confidence in its potential effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Inclusion Criteria

Your body mass index (BMI) must be between 18.0 and 30.0 kg/m^2.

Continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to screening and through discharge.

Be judged to be in good health (example, no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug or invasive procedure.

Exclusion Criteria

You are allergic to any part of the medicine TAK 105.

You currently have or may be at risk of getting COVID-19 infection according to the researcher.

Your heart rate should be between 55 and 100 beats per minute during the screening process. If your heart rate is below 50 or above 100 bpm during the treatment phase, the doctor will decide if you can still participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single dose of TAK-105-a or placebo and stay in the clinic for about 10 days

10 days

In-clinic stay

Follow-up Part 1

Participants return to the clinic for follow-up visits up to about 60 days after the dose

60 days

Multiple follow-up visits

Treatment Part 2

Participants receive TAK-105-a or placebo once a week for 4 weeks and stay in the clinic for about 26 days

26 days

In-clinic stay

Follow-up Part 2

Participants return to the clinic for follow-up visits up to about 60 days after last dose

60 days

Multiple follow-up visits

Treatment Part 3

Participants receive 2, 3, or 4 weekly doses of TAK-105-a or placebo and stay in the clinic for 10 to 24 days

10-24 days

In-clinic stay

Follow-up Part 3

Participants return to the clinic for follow-up visits up to about 28 days after last dose

28 days

Multiple follow-up visits

Treatment Part 4

Participants receive 2 doses (once a week for 2 weeks) of TAK-105-a or placebo, stay in the clinic for about 12 days, and return for a third dose

12 days + 2 days after third dose

In-clinic stay

Follow-up Part 4

Participants return to the clinic for follow-up visits up to about 3 months after first dose

3 months

Multiple follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• TAK-105

How Is the Trial Designed?

Group I: Part 2: TAK-105 Dose 2A Experimental Treatment 1 Intervention

TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.

Group II: Part 2: TAK-105 Dose 1A Experimental Treatment 1 Intervention

TAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks.

Group III: Part 1: TAK-105 Dose 7 Experimental Treatment 1 Intervention

TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.

Group IV: Part 1: TAK-105 Dose 6 Experimental Treatment 1 Intervention

TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.

Group V: Part 1: TAK-105 Dose 5 Experimental Treatment 1 Intervention

TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.

Group VI: Part 1: TAK-105 Dose 4 Experimental Treatment 1 Intervention

TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.

Group VII: Part 1: TAK-105 Dose 3 Experimental Treatment 1 Intervention

TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.

Group VIII: Part 1: TAK-105 Dose 2 Experimental Treatment 1 Intervention

TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.

Group IX: Part 1: TAK-105 Dose 1 Experimental Treatment 1 Intervention

TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.

Group X: Part 1: Placebo Placebo Group 1 Intervention

TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.

Group XI: Part 2: Placebo Placebo Group 1 Intervention

TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Published Research Related to This Trial

LYTAK1, a specific TAK1 inhibitor, effectively inhibits the growth of ovarian cancer cells while sparing normal ovarian epithelial cells, indicating its potential as a targeted therapy.

The mechanism of action involves inducing necrosis in ovarian cancer cells through mitochondrial permeability transition pore (mPTP) opening, and LYTAK1 also shows enhanced efficacy when combined with paclitaxel in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of ovarian cancer cell growth by a novel TAK1 inhibitor LYTAK1. Ying, L., Chunxia, Y., Wei, L.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04964258?tab=results

NCT04964258 | A Study of TAK-105 in Healthy Adults An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/60f5c5d0f883ca001e82d354

A Study of TAK-105 in Healthy Adults TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as follows: - To check for side effects from TAK-105 in ...

3. trial.medpath.com trial.medpath.com/clinical-trial/68bb3c1ca9aacce5/nct04964258-randomized-double-blind-placebo-controlled-phase-1-study-tak-105

A Study of TAK-105 in Healthy Adults | MedPath It is hoped that in the future, TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as follows:

4. withpower.com withpower.com/trial/phase-1-6-2021-85610

A Study of TAK-105 in Healthy Adults · Info for Participants This trial tests TAK-105 for nausea/vomiting in healthy adults (BMI 18-30, non-smoker, no disease) to find safe dosage levels. Related compounds showed ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/vanda-pharmaceuticals-motion-sickness-trial/

Vanda Pharmaceuticals reports data from motion sickness ... Results also showed that both doses of tradipitant were significantly more effective than the placebo. In the trial, only 10.4% and 18.3% of the ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-1-healthy-volunteers-tak-105-adults-trial-nct04964258

A Study of TAK-105 in Healthy Adults It is hoped that in the future, TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as ...

7. multi-sponsor-site-prod.s3.amazonaws.com multi-sponsor-site-prod.s3.amazonaws.com/takeda/studies/attachments/Plain_Language_Summary_-_English_VEwbInJ

This report may include approved and non- ... This study has helped researchers learn about the safety of TAK-105 in healthy adults. Researchers found that TAK-105 was tolerated at different doses by the ...