Phase 1
Completed N=40
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT03228433 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 4; 2; 2; 3 participants
Summary
The purpose of this study is to evaluate the safety and tolerability of TAK-418 following single oral doses in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
4; 2; 2; 3; 1; 3 | — |
| PRIMARY Number of Participants Who Discontinued Due to an Adverse Event (AE) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose |
0; 1; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose |
1; 2; 1; 0; 0; 0 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base) |
77.3; 290.4; 649.4; 616.2; 674.1; 1576.3 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F |
84.9; 296.3; 659.6; 626.0; 681.0; 1519.9 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-418F |
21.54; 61.90; 163.64; 94.93; 155.32; 321.52 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F |
1.000; 1.000; 1.000; 3.000; 1.250; 1.000 | — |
Eligibility Criteria
Inclusion Criteria
- Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.
- Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
- Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.
- Female subjects with no childbearing potential, defined by at least 1 of the following criteria:
- Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
- Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
- Had a tubal ligation with appropriate documentation of surgical procedure.
- Has a congenital condition resulting in no uterus.
Exclusion Criteria
- Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
- Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.
Data sourced from ClinicalTrials.gov (NCT03228433). 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.