Overview

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

Status:
Completed
Trial end date:
2019-04-15
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Treatments:
Esomeprazole
Proton Pump Inhibitors
Criteria
Inclusion Criteria:

1. 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.

2. 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.

Exclusion Criteria:

1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
first dosing.

2. 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.

3. Donation of blood or significant blood loss (example, approximately 500 milliliter
[mL]) within 56 days prior to the first dosing.

4. Plasma donation within 7 days prior to the first dosing.

5. 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.