Phase 1
Completed N=14
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
Source: ClinicalTrials.gov NCT02174523 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Lurasidone Cmax — 50.2 ng/mL
Summary
To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.
To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lurasidone Cmax |
48.5 | — |
| PRIMARY Lurasidone AUC 0-24 |
190 | — |
| PRIMARY Lurasidone AUC 0-τ |
234 | — |
| PRIMARY Lurasidone AUC0-∞ |
314 | — |
| PRIMARY Lurasidone Tmax |
1.75 | — |
| PRIMARY Lurasidone λz |
0.0199 | — |
| PRIMARY Lurasidone t1/2 |
34.9 | — |
| PRIMARY Lurasidone MRT |
22.0 | — |
| PRIMARY Lurasidone CL/F |
223 | — |
| PRIMARY CLss/F |
211 | — |
| PRIMARY Lurasidone Vz/F |
6198 | — |
| PRIMARY Lurasidone Vzss/F |
10618 | — |
| PRIMARY Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ, |
0.94; 1.74; 1.25; 2.52 | — |
| PRIMARY Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5 |
0.277; 1.15 | — |
| PRIMARY Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7 |
1.56; 2.00 | — |
Eligibility Criteria
Inclusion Criteria
- After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the informed consent form voluntarily.
- Male subjects are 18≤ age 6.2% at screening.
- Subjects with history of gastrointestinal operations (excluding appendectomy).
- Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
- Subjects with past history of allergy to drugs.
- Subjects have consumed grapefruit or food containing grapefruit ingredients between 7 days before medication (Day\_-7) and before administration of study drug on the medication day (Day 1). Subjects have consumed food containing hypericum perforatum L. ingredients between 14 days before medication (Day\_-14) and administration of study drug on the medication day (Day 1).
- Subjects have taken any drugs (including over-the-counter drugs) between 7 days before medication (Day\_-7) and before administration of study drug on medication day.
- Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
- Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or nutritional oral solution, etc).
- Subjects have history of drug abuse or positive urine drug tests.
- Subjects with positive immunologic test results.
- Average amount of daily smoking>20 cigarettes.
- Subjects have taken other study drugs within 3 months (Day\_-90~Day 1) before medication.
- Subjects received lurasidone orally before.
- Subjects have history of blood donations of 400 mL within 3 months (Day\_-90~Day 1) before medication; 200 mL within 1 month (Day\_-30~Day 1) before medication; or donation of blood components within 2 weeks (Day\_-14~Day 1) before medication.
- Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day\_-3) and before administration of study drug on medication day.
- Subjects can not tolerate venipuncture or have poor peripheral venous access.
- Subjects are unwilling to abstain from vigorous exercise from Day\_-1 until discharge.
- Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.
Data sourced from ClinicalTrials.gov (NCT02174523). 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.