Phase 1
Completed N=128
A Study of TAK-951 in Healthy Adults
Healthy Volunteers
Source: ClinicalTrials.gov NCT05567393 ↗
Enrolled (actual)
128
Serious AEs
0.8%
Results posted
Sep 2023
Primary outcomePrimary: Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings — 0; 0; 0; 0 percentage of participants
Summary
This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of this study in healthy adults 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.
* To check how much TAK-951 stays in the blood over time to work out the best dose.
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 Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters |
8.3; 0; 0; 16.7; 16.7; 33.3 | — |
| PRIMARY Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters |
0; 0; 16.7; 0; 0; 0 | — |
| PRIMARY Parts 1 and 3: Percentage of Participants With Treatment-Emergent Adverse Events |
16.7; 16.7; 16.7; 16.7; 16.7; 16.7 | — |
| PRIMARY Parts 1 and 3: Percentage of Participants With Positive Immunogenicity (ADA) Status |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-951 |
177; 213; 420; 383; 717; 2070 | — |
| SECONDARY Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951 |
813; 1960; 3920; 9230; 15300; 21700 | — |
| SECONDARY Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-951 on Day 1 |
1260; 6010; 22400; 33700 | — |
| SECONDARY Part 3: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval Tau (τ), From Time of First Daily Dose to 8 Hours for TAK-951 on Day 1 |
5420; 25000; 98100; 152000 | — |
Eligibility Criteria
Inclusion Criteria
- Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m^2) at the Screening Visit.
Exclusion Criteria
- The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the Screening Visit. Note: Participants with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
- The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the Screening Visit.
- Heavy consumption of alcohol within 3 months before screening (>7 drinks/week for women, >14 drinks/week for men, where 1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine and phencyclidine) within 1 year before Screening.
- The participant has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days before check-in (Day -1) or cotinine test is positive at Screening or Day -1.
- The participant has had 3 incidences of vasovagal syncope within the last 5 years.
- The participant has Brugada syndrome (right bundle branch block [RBBB] pattern with ST-elevation in leads V1-V3).
- The participant has an average semirecumbent systolic blood pressure 100 beats per minute (bpm) [at Screening, at Day -1, or at predose]; athletic participants with an average HR 120 bpm standing, will also be excluded.
Data sourced from ClinicalTrials.gov (NCT05567393). 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.