A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.
Key facts
- Study ID
- NCT03849690
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 12
- Starts
- 2019-02-27
- Expected to finish
- 2019-04-15
- Last updated by the study team
- 2021-06-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
- Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m\^2) at Screening.
You may not qualify if…
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- QT interval corrected using Fridericia's formula (QTcF) interval is greater than (>) 450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
- Donation of blood or significant blood loss (example, approximately 500 milliliter [mL]) within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30 day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Study Period 1 of the current study.
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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