Phase 1 Completed N=124 Randomized Double-blind Other

A Study of TAK-510 in Healthy Adults

Healthy Participants

Source: ClinicalTrials.gov NCT04731922 ↗

Enrolled (actual)

124

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcomePrimary: Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose — 0; 0; 0; 0 Participants

Summary

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting). The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it. The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study. At the first visit, the study doctor will check if each person can take part. For those who can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1 of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo will look like the TAK-510 injection but will not have any medicine in it. In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or placebo. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment. In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or placebo, once a day for 5 days. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment. In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit, they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each participant in this group will receive lower to higher doses of TAK-510. They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment. At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or placebo. This will happen 7 days after their last injection from the previous clinic visit. They will receive the same dose as their previous dose. They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment. After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.

Outcome Measures

Outcome	Result	p-value
PRIMARY Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose	0; 0; 0; 0; 0; 0	—
PRIMARY Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose	1; 0; 0; 0; 0; 0	—
PRIMARY Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose	1; 0; 0; 0; 0; 0	—
PRIMARY Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)	10; 1; 3; 3; 4; 6	—
SECONDARY Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens	—	—
SECONDARY Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for ECG Parameters at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens	—	—
SECONDARY Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens	—	—
SECONDARY Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens	—	—
SECONDARY Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum	20; 6; 6; 6; 7; 6	—
SECONDARY Part 3: Number of Participants Based on ADA Status (Positive and Negative) in Serum	—	—
SECONDARY Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer	3; 0; 0; 0; 0; 0	—
SECONDARY Part 3: Number of ADA Positive Participants Based on Low or High ADA Titer	—	—

Eligibility Criteria

Inclusion Criteria

Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to ( =20 mmHg or a decrease in diastolic BP >=10 mmHg at approximately 3 minutes of standing when compared with BP from the semirecumbent position, at screening to predose assessments, inclusive. In asymptomatic participants, any assessments after screening that do not meet this criterion may be repeated after the participant has remained in the semirecumbent or supine position for 15 minutes. If the repeat assessment is exclusionary based on the above criterion, the participant will not be eligible. If the repeat assessment is not exclusionary, the participant will be eligible.
Has postural orthostatic tachycardia, defined as an increase of greater than (>) 30 beats per minute (bpm) or heart rate (HR) >120 bpm at approximately 3 minutes, of standing, at screening to predose assessments, inclusive. Any assessments after screening that do not meet this criterion may be repeated with the participant remaining standing for up to a total of 5 minutes, provided that the participant remains asymptomatic. If the repeat assessment occurring within 5 minutes is exclusionary based on the above criterion, the participant will not be eligible. A confirmed orthostatic increase of >30 bpm, but less than (<) 40 bpm, on 1 or more Day -1 assessments may not be considered exclusionary if not considered clinically significant by the investigator and the medical monitor. Such assessments must be discussed with the medical monitor prior to determination that the participant is eligible to proceed.
Has a known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.

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Data sourced from ClinicalTrials.gov (NCT04731922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.