Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGTAK-438
TAK-438 tablets
DRUGClarithromycin
Clarithromycin tablets
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. In the opinion of the investigator the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is a healthy adult male participant, of non-Japanese origin. 4. Is aged 18 to 45 years, inclusive, at the time of informed consent and first study medication dose. 5. Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30 kg/m\^2, inclusive at Screening. 6. A male participant who is sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. 7. Has clinical laboratory evaluations (including clinical chemistry, hematology, and urinalysis), within the reference range for the testing laboratory. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion unless these are specifically identified in the
Exclusion criteria
. 8. Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up call. 9. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call. 10. Is willing to provide a sample for pharmacogenomic analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-438 and TAK-438 Metabolites (M-I, M-II, M-III, M-IV-Sul) | 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) | 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) | 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) | Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Markedly Abnormal Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose | Screening (Days -28 to -2) up to Day 10 |
| Ratio of TAK-438 Metabolites Cmax to TAK-438 Cmax | 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 | Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Day 1 until Day 14 or early termination |
| Ratio of TAK-438 Metabolites AUC(0-24) to TAK-438 AUC(0-24) | Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Predose Observed Plasma Concentration of Clarithromycin | Days 3 to 9 pre-dose (-1 hours [1 hour before TAK-438 dosing]) and (11 hours [11 hours after TAK 438 dosing]) |
| Ratio of TAK-438 Metabolites AUC∞ to TAK-438 AUC∞ | Days 1 and 8 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Percentage of Participants With Markedly Abnormal Laboratory Values | Screening (Days -28 to -2) up to Day 10 |
| Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose | Screening (Days -28 to -2) up to Day 10 |
| Percentage of Participants With Clinical Significant Change in Physical Examination | Screening (Days -28 to -2) up to Day 10 |
Outcome results
None listed