Phase 1
Completed N=32
A Study of TAK-951 in Healthy Adults
Healthy Volunteer
Source: ClinicalTrials.gov NCT04486950 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs) — 1; 0; 1; 3 Participants
Summary
It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in healthy adults.
The main aims of this study are as follows:
* To check for side effects from TAK-951 when given at a slow and fast infusion rate.
* To learn how much TAK-951 participants can receive without getting side effects from it.
Participants will receive a single infusion of either TAK-951 or placebo. In this study, a placebo looks like TAK-951 but does not have any medicine in it. Participants will receive either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.
Participants will stay in the study clinic for about 4 days to receive the study medicine (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the clinic about 2 weeks and 4 weeks after treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs) |
1; 0; 1; 3; 1; 3 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Laboratory Values |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951 |
2.758; 110.4; 127.7; 133.2 | — |
| SECONDARY Ceoi: Plasma Concentration at the End of Infusion for TAK-951 |
0.5203; 48.95; 37.03; 27.06 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951 |
2.722; 110.0; 127.2; 132.5 | — |
| SECONDARY T1/2z: Terminal Disposition Phase Half-life for TAK-951 |
4.025; 4.670; 4.454; 4.640 | — |
| SECONDARY λz: Terminal Disposition Phase Rate Constant for TAK-951 |
0.1781; 0.1501; 0.1574; 0.1500 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Continuous non-smoker who has not used nicotine- and tobacco-containing products and/or cannabis 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 ( =120 msec or PR interval greater than (>) 200 msec at screening or Day -1 pre-Hour 0.
- Documented history of sinoatrial block or sinus pause >=3 seconds.
- Semi-recumbent blood pressure (average of duplicate) is less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Has an average semi-recumbent heart rate 100 beats per minute (bpm) (at screening, at Day -1 pre-Hour 0, or at pre-dose Day 1); athletic participants with an average semi-recumbent heart rate =20 mmHg or a decrease in diastolic blood pressure >=10 mmHg after 2 minutes of standing when compared with blood pressure from the semi-recumbent position at screening and at Day -1 pre-Hour 0. The semi-recumbent blood pressure will be an average of duplicate measurements.
- Has postural orthostatic tachycardia, defined as an increase of 30 bpm or heart rate >120 bpm after standing for 2 minutes.
- Positive urine drug or alcohol results at screening or check-in.
- Positive urine cotinine at screening or check-in.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Thyroid hormone replacement medication may be permitted if the participant has been on same stable dose for the last 3 months prior to study drug administration. After dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Hormone replacement therapy will also be allowed.
- 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 dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to dosing.
- Plasma donation within 7 days prior to dosing.
- Has positive results for Coronavirus disease 2019 (COVID-19) testing at screening or check-in.
Data sourced from ClinicalTrials.gov (NCT04486950). 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.