A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.
Key facts
- Study ID
- NCT03870555
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 6
- Starts
- 2019-03-08
- Expected to finish
- 2019-05-16
- Last updated by the study team
- 2020-06-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32 kilogram per square meter (kg/m\^2), weighing >=50 kilogram (kg) at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as deemed by the Investigator or designee.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study, based on participant self-reporting.
You may not qualify if…
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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