Phase 1
N=33
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT03085836 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 — 9.148; 18.18; 25.23; 38.32 nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-438 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
9.148; 18.18; 25.23; 38.32; 67.95; 59.02 | — |
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
1.750; 2.000; 2.500; 1.500; 1.500; 2.000 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
84.38; 188.1; 226.8; 305.7; 617.2; 578.7 | — |
| PRIMARY AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
74.91; 168.6; 154.8; 251.4; 528.8; 344.1 | — |
| PRIMARY T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
7.879; 6.996; 7.116; 10.82; 8.256; 8.385 | — |
| PRIMARY Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 |
11.01; 23.43; 37.88; 43.39; 79.85; 59.55 | — |
| PRIMARY Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 |
1.500; 2.000; 3.000; 1.500; 1.000; 2.500 | — |
| PRIMARY AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 |
93.90; 212.7; 273.4; 285.5; 581.1; 435.3 | — |
| PRIMARY Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
448.5; 890.3; 1478; 176.6; 253.1; 211.2 | — |
| PRIMARY Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
4.485; 4.448; 7.399; 1.760; 1.262; 1.053 | — |
| PRIMARY CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 |
5.443; 4.922; 6.733; 0.6235; 0.4465; 0.3753 | — |
| PRIMARY Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 |
437.7; 859.9; 1327; 224.3; 354.1; 340.9 | — |
| PRIMARY Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 |
4.377; 4.299; 6.634; 2.236; 1.765; 1.700 | — |
| PRIMARY CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 |
4.848; 4.251; 4.977; 0.8126; 0.6207; 0.7943 | — |
Summary
The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.
Eligibility Criteria
Inclusion Criteria
- Is a healthy adult male or female Chinese participant.
- Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
- Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
- Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
- Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
- Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).
Exclusion Criteria
- Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
- Has poor peripheral venous access.
- Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
- Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
Data sourced from ClinicalTrials.gov (NCT03085836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.