Status:
COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.
Detailed Description
The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03870555
Start Date
March 8 2019
End Date
May 16 2019
Last Update
June 24 2020
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283