A Study of TAK-951 in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05567393

Run by

Takeda

People needed

128

Starts

2019-03-07

Expected to finish

2020-11-02

Last updated by the study team

2023-09-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m\^2) at the Screening Visit.

You may not qualify if…

• 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 <90 millimeters of mercury (mm Hg) or diastolic blood pressure <60 mm Hg at Screening or admission.
• The participant has an average heart rate (HR) <60 or >100 beats per minute (bpm) [at Screening, at Day -1, or at predose]; athletic participants with an average HR <60 bpm can be enrolled only with medical monitor approval.
• The participant has orthostatic hypotension defined as a decrease in systolic blood pressure ≥20 mm Hg or a decrease in diastolic blood pressure ≥10 mm Hg after 2 minutes of standing when compared with blood pressure from the sitting position at Screening, and at Day -1. Participants with postural orthostatic tachycardia, defined as HR >120 bpm standing, will also be excluded.

Where it is running

• California Clinical Trials Medical Group — Glendale, California, United States

Full record on ClinicalTrials.gov

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