The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants following a single oral dose of TAK-438.
The drug being tested in this study is called TAK-438. TAK 438 is being tested to assess the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438. The study will enroll approximately 16 healthy adult male participants of non-Japanese origin. Participants will be assigned: * TAK-438 40 mg * Clarithromycin 500 mg All participants will be asked to take 2 tablet of TAK-438 20 mg orally, once on Days 1 and 8 along with Clarithromycin 500 mg, tablets, orally twice daily from Days 3 to 9. This single center trial will be conducted in Europe. The overall time to participate in this study is maximum of 44 days. Participants will be confined to site for 10 days, and a final visit after 4 days after discharge from the unit for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
TAK-438 tablets
Clarithromycin tablets
Cmax: Maximum Observed Plasma Concentration for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul)
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Ratio of TAK-438 Metabolites Cmax to TAK-438 Cmax
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Ratio of TAK-438 Metabolites AUClast to TAK-438 AUClast
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Ratio of TAK-438 Metabolites AUC∞ to TAK-438 AUC∞
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Ratio of TAK-438 Metabolites AUC(0-24) to TAK-438 AUC(0-24)
Time frame: Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose
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Predose Observed Plasma Concentration of Clarithromycin
Time frame: Days 3 to 9 pre-dose (-1 hours [1 hour before TAK-438 dosing]) and (11 hours [11 hours after TAK 438 dosing])
Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Day 1 until Day 14 or early termination
Percentage of Participants With Markedly Abnormal Laboratory Values
Time frame: Screening (Days -28 to -2) up to Day 10
Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose
Time frame: Screening (Days -28 to -2) up to Day 10
Percentage of Participants With Markedly Abnormal Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose
Time frame: Screening (Days -28 to -2) up to Day 10
Percentage of Participants With Clinical Significant Change in Physical Examination
Time frame: Screening (Days -28 to -2) up to Day 10