Phase 1
Completed N=16
A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants
Healthy Volunteer
Source: ClinicalTrials.gov NCT02541669 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 — 2877; 6250; 2444; 5460 nanogram per milliliter (ng/mL)
Summary
The purpose of this study is to assess the pharmacokinetics and safety of single- and multiple-dose of TAK-491 in healthy Chinese participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 |
2877; 6250; 2444; 5460 | — |
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10 |
3070; 6019; 2628; 6226 | — |
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 |
3.03; 2.50; 3.00; 2.50 | — |
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10 |
3.00; 2.52; 3.49; 2.00 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 |
25905; 50359; 23439; 45698 | — |
| PRIMARY AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10 |
25087; 45320; 21872; 47993 | — |
| PRIMARY Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 |
11.18; 10.18; 11.12; 11.10 | — |
Eligibility Criteria
Inclusion Criteria
- Is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is a healthy adult male or female of Chinese descent.
- Is aged 18 to 45 years, inclusive, at the time of informed consent and first study medication dose.
- Has a body mass index (BMI) greater than or equal to (>=) 19.0 kilogram per square meter (kg/m^2) and less than ( ) 1.5 times the upper limits of normal.
- Has a hemoglobin value =160 millimeter of Mercury (mmHg) or a diastolic blood pressure =100 mmHg at Screening or Check-in (Day -1).
Data sourced from ClinicalTrials.gov (NCT02541669). 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. Informational only — not medical advice.