Rifampin Drug-Drug Interaction Study With Lurasidone HCl
- Registration Number
- NCT01082276
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- 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).
- 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
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Use of concomitant medications that prolong the QT/QTc interval from 14 days prior to day - 2 to discharge.
- Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to study Day -2
- Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever was longer) prior to Screening.
- Previous exposure to lurasidone (SM-13496).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rifampin/Lurasidone Lurasidone HCl Healthy Normal Subject
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PAREXEL Clinical Pharmacology Research Unit
🇺🇸Baltimore, Maryland, United States