Phase 1
Completed N=82
TAK-114 Single- and Multiple-Dose Phase 1 Study
Clinical Pharmacology
Source: ClinicalTrials.gov NCT02286518 ↗
Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) — 0; 0; 1; 1 participants
Summary
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) |
0; 0; 1; 1; 1; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Body Weight |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax - Maximum Observed Plasma Concentration for TAK-114 |
53.15; 68.74; 168.1; 30.98; 74.72; 140.8 | — |
| SECONDARY AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 |
469.2; 762.2; 1708; 472.3; 879.2; 2180 | — |
| SECONDARY AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 |
251.3; 838.0; 183.2; 749.7 | — |
| SECONDARY Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 |
4.108; 5.500; 5.272; 7.417; 5.822; 6.213 | — |
| SECONDARY Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 |
0.2368; 0.3606; 0.2125; 0.3190 | — |
| SECONDARY Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3 |
0.3032; 0.4768; 0.3128; 0.4087 | — |
| SECONDARY Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 |
0.003835; 0.001984; 0.002759; 0.003724; 0.003143; 0.002420 | — |
Eligibility Criteria
Inclusion Criteria
Healthy Japanese participants:
- Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- Is aged 20 to 45 years, inclusive.
- Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m^2).
Healthy Caucasian participants:
- Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
- Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.
Exclusion Criteria
- Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
Data sourced from ClinicalTrials.gov (NCT02286518). 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.