Male, Healthy Normal Subjects
Conditions
Keywords
Rifampin DDI with Lurasidone HCl
Brief summary
The effect of rifampin on the pharmacokinetics of lurasidone
Detailed description
by performing an open-label, 2-period, sequential study in healthy subjects. All subjects (N=20) will be assigned to the same treatment sequence, 40 mg po dosing.
Interventions
DRUGLurasidone HCl
40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female subjects must be of nonchildbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or post-menopausal ≥ 1 year) with follicle stimulating hormone \[FSH\] \> 40 U/L). 2. Subjects with partners of child-bearing potential must agree to use barrier contraception during the study and for 90 days after discharge. Volunteers must agree to not donate sperm during the study and for 90 days after discharge.
Exclusion criteria
1. Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs. 2. Use of concomitant medications that prolong the QT/QTc interval from 14 days prior to day - 2 to discharge. 3. Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to study Day -2 4. Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever was longer) prior to Screening. 5. Previous exposure to lurasidone (SM-13496).
Countries
United States
Outcome results
None listed