A Study of TAK-105 in Healthy Adults

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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TAK-105 to see if it can safely treat nausea and vomiting. Healthy adults are participating to help researchers find out if the drug has any side effects and what the safe dosage levels are.

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 TAK-105 safe for humans?

There is no specific safety data available for TAK-105, but related compounds like TAK-242 have been studied in rats, showing potential protective effects against brain injury by reducing inflammation and cell damage. ^{1 2 3 4 5}

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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

Treatment Details

Interventions

• TAK-105

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Paclitaxel induces apoptosis through the TAK1-JNK activation pathway. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Enhancement of hyperthermia-induced apoptosis by 5Z-7-oxozeaenol, a TAK1 inhibitor, in Molt-4 cells. [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Effect of TAK1 gene silencing on the apoptosis of Kasumi-1 cells induced by arsenic trioxide]. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Inhibition of ovarian cancer cell growth by a novel TAK1 inhibitor LYTAK1. [2015]

5. Poland pubmed.ncbi.nlm.nih.gov

TAK-242, a toll-like receptor 4 antagonist, against brain injury by alleviates autophagy and inflammation in rats. [2023]