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: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/28/2019 |
| Start Date: | February 27, 2019 |
| End Date: | March 30, 2019 |
| Contact: | Takeda Study Registration Call Center |
| Email: | medicalinformation@tpna.com |
| Phone: | +1-877-825-3327 |
A Single-Sequence, Open-Label, 2-Period, Crossover Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects
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.
esomeprazole on the single-dose PK of orally administered TAK-906.
The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy
participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.
The study will enroll approximately 12 participants. Participants will be assigned to the
following treatment sequence:
• TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg
All participants will be given an oral dose of TAK-906 and Esomeprazole.
This single center trial will be conducted in the United States. The overall duration to
participate in this study is 52 days. Participants will make visit to the clinic during
Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last
dose of TAK-906 for a follow up assessment.
participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.
The study will enroll approximately 12 participants. Participants will be assigned to the
following treatment sequence:
• TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg
All participants will be given an oral dose of TAK-906 and Esomeprazole.
This single center trial will be conducted in the United States. The overall duration to
participate in this study is 52 days. Participants will make visit to the clinic during
Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last
dose of TAK-906 for a follow up assessment.
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.
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