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NCT04964258 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-105 in Healthy Adults
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT04964258 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 80 participants.
The verdict
NCT04964258, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
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: * To check for side effects from TAK-105 in healthy adults. * To learn how much TAK-105 they can receive without getting side effects from it. Participants will receive either TAK-105 as TAK-105-a or TAK-105-b (depending upon the part they are enrolled in) or a placebo as an injection under the skin (sub-cutaneous injection). A placebo looks like TAK-105-a or TAK-105-b but will not have any medicine in it. Three times as many participants will receive TAK-105-a or TAK-105-b than placebo. The study will have 6 parts. Each part will have several small groups of participants, called cohorts. Participants will only be in 1 cohort in 1 part of the study. Part 1: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose. Part 2: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose. Part 3: Participants will check into the study clinic to receive 2, 3 or 4 weekly doses of TAK-105-a or placebo. Their clinic stay will be for 10 to 24 days depending which cohort they are in. Then, participants return to the clinic for follow-up visits up to about 28 days after last dose. Part 4: Participants will check into the study clinic to receive 2 doses (once a week for 2 weeks) of TAK-105-a or placebo and will stay in the study clinic for about 12 days. They will return to the clinic later (in about 1-3 weeks) for another (third) dose and will stay for 2 days after the third dose. Then, participants return to the clinic for follow-up visits up to about 3 months after fir
Interventions
- DRUG TAK-105-a
- DRUG TAK-105-a Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04964258
The ClinicalTrials.gov registry entry for NCT04964258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TAK-105-a is the first listed.
NCT04964258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04964258 about?
NCT04964258 is a clinical study titled "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 follows: * To check for side effects from TAK-105 in healthy adults. * To learn how much TAK-105 they can receive without getting side effects from it. Participant...
What is the current status of trial NCT04964258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2021-07-26. Estimated completion is 2023-06-20.
What interventions are being tested in trial NCT04964258?
The interventions under investigation include: TAK-105-a (DRUG), TAK-105-a Placebo (DRUG).
Who is sponsoring clinical trial NCT04964258?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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